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Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition. CRC Biostatistics Series  Volume: 27 Shein-Chung Chow & Jen-pei Liu. due September 2008. Provides detailed descriptions of current statistical concepts, methodologies, regulatory policies, and public debates; Reviews the recent guidelines on bioequivalence studies issued by the USFDA; Includes five additional chapters in this edition; Focuses on practical concepts rather than technical details. Maintaining the same practical viewpoint as its bestselling predecessors, this third edition presents a comprehensive, unified summary of the vast and continually growing literature and research activities in the field. It focuses on regulatory requirements, current scientific and practical issues, and the statistical methodology of designing and analyzing bioequivalence studies. The preeminent authors cover the assessment of food effect on bioequivalence, bioequivalence for drugs with local action, the qualitative determination of pharmaceutical equivalence, bioequivalence for biological products, medical devices, the use of genomic information in assessing bioequivalence, and ethnical and gender differences in assessing bioequivalence. ISBN: 9781584886686; ISBN 10: 1584886684. Number of Pages: 760.  $99.95

Validation of Cell-Based Assays in the GLP Setting: A Practical Guide. Uma Prabhakar (Editor), Marian Kelley (Editor). 2008. The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines. In this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development. This book: 

• Describes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice
• Presents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results
• Provides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines
• Offers a compendium of validation parameters that need to be considered when using these methods to develop a new drug
• Includes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics

Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development. ISBN: 978-0-470-02876-6. Hardcover. 312 pages. $150.00

Pharmaceutical Dosage Forms: Tablets, Third Edition Volume 1: Unit Operations and Mechanical Properties. Larry L. Augsburger & Stephen W. Hoag. 2008. Pharmaceutical Dosage Forms: Tablets, Volume 1 examines the fundamental physical and chemical processes that the different unit oprations use, and then applies this knowledge to the discussion of the varying unit operations and processes. ISBN: 9780849390142; ISBN 10: 0849390141, Number of Pages: 656. List Price: $199.95

Pharmaceutical Dosage Forms: Tablets, Third Edition Volume 2: Rational Design and Formulation. 2008.  Pharmaceutical Dosage Forms: Tablets, Third Editionis acomprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form.  The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients; Volume 2 focuses on the rational design, and formulation of a tablet and includes chapters with practical illustrations and formulation examples. ISBN: 9780849390159; ISBN 10: 084939015X. Number of Pages: 568. List Price: $199.95

Pharmaceutical Dosage Forms: Tablets, Third Edition Volume 3: Manufacture and Process Control. Larry L. Augsburger & Stephen W. Hoag. Publication Date: 6/3/2008. This text addresses testing and evaluation of tablets, and setting up specification for manufacture; focuses on new regulatory policies that address international harmonization and proposes the use of modern process analyzers or process analytical chemistry tools to achieve real-time control and quality assurance during manufacturing. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form.  Volume 3 ties the other volumes in the Third Edition together to show how the information learned in the previous chapters fits together to make tablet on a commercial scale. ISBN: 9780849390166; ISBN 10: 0849390168 Number of Pages: 328. List Price: $199.95

Pharmaceutical Dosage Forms: Tablets, Third Edition (Three-Volume Set). Larry L. Augsburger & Stephen W. Hoag

List Price: $549.95
ISBN: 9781420063455
ISBN 10: 1420063456

Pharmaceutical Project Management, Second Edition. Anthony Kennedy. Series: Drugs and the Pharmaceutical Sciences  Volume: 182 

List Price: $199.95
ISBN: 9780849340246
ISBN 10: 0849340241
Publication Date: 3/17/2008
Number of Pages: 280

New updated material to include:

·  expert recommendations and informative articles on decision-making

·  resource allocation

·  system selection

·  team leadership

·  skill sets strategies

·  planning principles It covers primary project management objectives, functions, and descriptions of the nature and execution of work activities in a clear and reader-friendly format to illustrate key characteristics and objectives, assist managers in projecting the risks and challenges of each position, and supply concise recommendations for successful project planning. Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through manufacturing and launch.

 Drug-Drug Interactions, Second Edition. A. David Rodrigues. Series: Drugs and the Pharmaceutical Sciences  Volume: 179

·  expands coverage of Michaelis-Menten kinetics describing enzyme-catalyzed biotransformation reactions to include non-Michaelis kinetics

·  presents state-of-the-science knowledge related to the different influx (SLT) and efflux (ABC) transporters

·  describes different approaches for studying the structure and function of human cytochromes P450

·  discusses in silico (computer-based) approaches used by researchers in the field of drug interactions

Helping researchers predict drug interactions in a more accurate and effective manner, this comprehensive volume covers every critical aspect of metabolism-based drug-drug interactions, including preclinical, clinical, toxicological, regulatory, and marketing perspectives by renowned thought leaders in their respective fields. Thoroughly updated, the Second Edition reflects key developments in the field, including an improved understanding of the relationship between transporters and enzymes in drug metabolism and drug interactions. Formatted to benefit the reader, this source provides helpful case examples, representative enzyme systems, and computer-aided modeling, as well as 200 valuable tables, equations, drawings, and photographs to clarify key concepts. List Price: $249.95
ISBN: 9780849375934
ISBN 10: 0849375932
Publication Date: 2/8/2008
Number of Pages: 768

Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition. Stephen P. Denyer & Rosamund Baird .2006.

• Surveys both traditional and rapid techniques for monitoring microbiological quality
• Focuses on practical issues in product development and regulatory requirements Offers guidance on risk assessment Discusses sampling techniques and antimicrobial preservation
• Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Nowadays, all scientists working in product development and production need to be versed in modern methods of contamination control.
• Updated to reflect the technological and regulatory changes that have come into play since publication of the first edition, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers those principal aspects of microbiology that are relevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals, while expanding the book's focus to include medical devices.

In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores monitoring microbiological quality, the preservation of pharmaceutical formulations and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity testing, and the evaluation of contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. Concerns with contamination will continue to be inextricably linked to the development of pharmaceuticals and medical devices. Many new methods and regulations have been developed to meet those concerns. This book provides a comprehensive distillation of information that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development. Number of Pages: 608. ISBN: 0748406158. $159.95

Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, Sixth Edition. Series: Drugs and the Pharmaceutical Sciences Volume: 169. Joseph Nally. 2006. Building on the solid foundation of the Fifth Edition and previous editions, this Sixth Edition provides readers with fundamental knowledge of CGMP regulations and current industry applications and practices. Each chapter has been updated and this text supplies new and must-have information regarding the latest FDA guidance documents quality systems approach risk analysis and management :

• contracting and outsourcing
• GMPs and clinical supplies
• bulk pharmaceutical excipient GMPs
• equipment maintenance and calibration
• failure investigations
• FDA enforcement tools
• worldwide GMPs
• ISO 9000 and Malcolm Baldrige approaches, and Six Sigma methodology

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. Number of Pages: 700. ISBN: 0849339723. $249.95

Environmental Monitoring for Cleanrooms and Controlled Environments. Series: Drugs and the Pharmaceutical Sciences Volume: 164. Anne Marie Dixon. 2006. Providing must-have information on the entire subject of environmental monitoring, this text presents background information on the performance of aerosols in cleanrooms or controlled environments provides sections on particle, viable air, and surface monitoring, which include considerations for optimal equipment selection, operation, maintenance, data generation and analysis, and management discusses aseptic processing simulations in clear and concise terms to ensure acceptability of the process . A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient. Number of Pages: 256. ISBN: 0824723597. $199.95

Pharmaceutical Isothermal Calorimetry. Simon Gaisford & Michael A. A. O'Neill. 2006. Offering a problem-based approach to the material, with numerous examples, this source provides an in-depth user guide that offers step-by-step instruction on experimental set-up, calibration, and new methods of data analysis presents best practices in experimentation and discusses the principles of calibration in reference to the latest IUPAC guidelines simplifies data analysis and interpretation and covers recent methods by pioneering researchers on the topic utilizes case studies to highlight specific applications discussed in the text covers current techniques in stability testing, screening, and storage temperature stability assessment. Pharmaceutical Isothermal Calorimetry discusses the application of isothermal calorimetric techniques to challenges encountered during the rational design and development of novel drugs and drug delivery systems. Providing a comprehensive review of recent research and trends, this book contains an expert discussion of research and applications to pharmaceutical characterization and formulation. 376 pp. ISBN: 0849331552. $199.95

Encyclopedia of Pharmaceutical Technology, Third Edition - 6 Volume Set (Print) James Swarbrick. 2006. Bringing together acknowledged leaders from every specialty related to pharmaceutical technology, this Third Edition stands as an indispensable and single-source reference at the forefront of pharmaceutical technology and research keeps pharmaceutical professionals and researchers at the cutting-edge of their disciplines with more than 70 NEW entries on topics of utmost importance in the field including advances in systems validation, processing techniques, patent issues, noninvasive drug delivery, and the commercialization of drugs and dosage forms provides a comprehensive overview of most specialty and subspecialty topics relating to the research, manufacture, marketing, and use of pharmaceuticals offers a reader-friendly and timely collection of references to the pharmaceutical market contains an abundance of articles on pharmaceutics, pharmacokinetics, analytical chemistry, quality assurance, drug safety, and manufacturing processes. Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to come, the Third Edition will offer completely new entries that cover critical issues in the field such as the impact of genomics, biotechnology, and implants on drug discovery, targeting, delivery, and formulation. In addition, it will address new regulatory issues, such as the changes in advertising regulations, and emerging FDA procedures. 5536 pp. ISBN: 084939399X. $3,495.95

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries: Second Edition. Syed Imtiaz Haider. 2006. Expertly leading readers through the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry, this source provides 139 ready-to-use Master Validation procedures, template protocols, and reports supplies a CD-ROM with a template of customizable validation standard operating procedures includes examples of 11 critical qualification and re-qualification reports presents 14 exclusive environmental performance evaluation procedures provides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United States includes step-by-step guidelines for translating GMP requirements into action. Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control. 1144 pp. ISBN: 0849395291. $269.95

Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, Sixth Edition. Series: Drugs and the Pharmaceutical Sciences Volume: 169. Joseph Nally. 2006. Building on the solid foundation of the Fifth Edition and previous editions, this Sixth Edition provides readers with fundamental knowledge of CGMP regulations and current industry applications and practices. Each chapter has been updated and this text supplies new and must-have information regarding the latest FDA guidance documents quality systems approach risk analysis and management. includes:

• contracting and outsourcing
• GMPs and clinical supplies
• bulk pharmaceutical excipient GMPs
• equipment maintenance and calibration
• failure investigations
• FDA enforcement tools
• worldwide GMPs
• ISO 9000 and Malcolm Baldrige approaches
• Six Sigma methodology

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings. Number of Pages: 700. ISBN: 0849339723. $169.95

Pharmaceutical Photostability and Stabilization Technology. Series: Drugs and the Pharmaceutical Sciences Volume: 163.  Joseph T. Piechocki & Karl Thoma. 2006. This guide assists in the selection of the most appropriate photon source and actinometer for specific applications devotes an entire chapter on the study of chemical actinometry-a stable, self-standardizing method of radiation dosage assessment focuses attention on molecular mechanisms and kinetics and their importance in the development of protective measures offers reviews of the available testing chambers for pharmaceutical photochemical studies details protective methods for all dosage forms useful in preventing photodegradation includes information on the use, action, and methods of determination of the effectiveness and stabilization of sunscreens. Based on a training course developed by Dr. Joseph T. Piechocki and other experts in this field whose contributions appear in this book for two International Meetings on the Photostability of Drugs and Drug Products, this text clarifies the guidelines set by the International Conference on Harmonization (ICH) and provides a comprehensive background in the scientific principles involved in photostability testing. Presenting the advantages and disadvantages of various procedures so the reader can select and utilize the most appropriate technique best-suited to their needs, this source includes references to current literature in the field and offers an opinion on future opportunities and challenges. Number of Pages: 445. ISBN: 0824759249. $199.95

Laboratory Auditing For Quality and Regulatory Compliance. Publication Date: 6/20/2005. Donald Singer, Raluca-Ioana Stefan & Jacobus van Staden. Series: Drugs and the Pharmaceutical Sciences Volume: 150. Completely revised and expanded, this up-to-date source assists in the assessment of laboratory procedures in preparation for an external auditor; reflects the impact of computers and information technologies on data generation, analysis, and storage; offers a global perspective on laboratory management and quality control; serves as a comprehensive guide to the design of an effective audit for enhanced laboratory operation. Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance. Number of Pages: 352. ISBN: 1574445707. List Price: $139.95

Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation. Publication Date: 5/26/2005. Stanley Nusim. Series: Drugs and the Pharmaceutical Sciences Volume: 151. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute the manufacturing of quality APIs; studies the process development task, as well as plant design, construction, and operation; reviews the latest regulatory standards in this rapidly changing market; details validation procedures for bulk pharmaceutical chemicals discusses the unique aspects of the quality function in the API industry. Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety. Number of Pages: 368. ISBN: 082470293X. List Price: $139.95

Pharmaceutical Stress Testing: Predicting Drug Degradation. Publication Date: 6/21/2005. Steven W Baertschi. Series: Drugs and the Pharmaceutical Sciences Volume: 153. Richly illustrated and extensively referenced, this source details the execution and interpretation of small molecule stress testing studies; provides a comprehensive overview of the major aspects of the prediction of drug degradation; presents up-to-date approaches to pharmaceutical stress testing discusses the historical context and regulatory framework of stress testing; critically addresses currently utilized methodologies and experimental designs; addresses difficult problems such as mass balance, analytical limitations, and drug-excipient interactions; examines major mechanisms of degradation chemistry in the context of common functional groups; offers alternative approaches to the study of drug stability and degradation with computational approaches and microcalorimetry contains special coverage of freeze-drying processes; provides quick reference to the problems frequently encountered by pharmaceutical researchers. The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature. Number of Pages: 488. ISBN: 0824740211. List Price: $199.95

Polymeric Drug Delivery Systems. Glen S Kwon University of Wisconsin, Madison, Wisconsin, USA. Series: Drugs and the Pharmaceutical Sciences Volume: 148. Publication Date: due May 2005. Offering specific examples of polymeric drug delivery systems that have entered clinical trials or clinical practice, this handbook contains; -a comprehensive historical perspective on N-(2-hydroxypropyl)methacrylamide copolymer conjugates; -innovative approaches for oral drug delivery based on hydrogels; -a critical summary of the development of biodegradable polyanhydrides for local chemotherapy of brain tumors; -the latest advances to improve protein stability in biodegradable microspheres; -critical issues concerning nanoparticulate delivery systems for cancer vaccines; -a detailed examination of polymeric micelles for the targeting of anticancer drugs; -an in-depth summary of synthetic efforts toward graft copolymers for gene delivery; -the latest developments in self-assembling polymers for gene delivery. Emphasizing four major classes of polymers for drug delivery-water-soluble polymers, hydrogels, biodegradable polymers, and polymer assemblies-this reference surveys efforts to adapt, modify, and tailor polymers for challenging molecules such as poorly water-soluble compounds, peptides/proteins, and plasmid DNA. Number of Pages: 680. ISBN: 0824725328. List Price: $199.95

Write it Down: Guidance for Preparing Effective and Compliant Documentation, Second Edition. Janet Gough Industry Consultant, Flanders, New Jersey, USA. Publication Date: 3/30/2005. Includes: -examples for clinical trials; -Provides specifics of writing documentation for regulatory purposes; -Gives examples of reports as well as process, periodic, and progress reports. This book covers writing for the FDA as it applies to the pharmaceutical industry. It presents a brief overview of the regulatory environment and documentation requirements, identifies the roles of writers and readers, and discusses the purpose of good documentation. The book offers documents and representative writing samples from throughout the industry, ranging from the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to complete writing tasks effectively. This new edition includes examples of various forms of representation of data and other illustrative materials that accompany documents needed by the FDA. Number of Pages: 504. ISBN: 0849321719. List Price: $229.95

Dictionary of Drugs on CD-ROM. C.R. Ganellin University College London, UK & David J Triggle State University of New York at Buffalo, USA. Publication Date: 3/29/2005. Presenting over 12,300 entries with accurate, up-to-date and concise information on 45,722 compounds, Dictionary of Drugs on CD-ROM is a one-stop resource for the medicinal chemist. As well as chemical and structural data, this database also offers mechanisms of drug action, octanol/water partition coefficients, marketing status plus literature references to pharmacological studies. In addition - for the top 1500 drugs - monographs are hyperlinked from the renowned PDR® (Physician's Desk Reference) Generics™, providing a wealth of pharmacokinetic and pharmacological data:

• · Accurate systematic chemical names, generic names, trade names, trivial names
• · Searchable chemical structures
• · CAS Registry numbers
• · Molecular formulae and weights
• · Physical data including octanol/water partition coefficients, melting/boiling points, dissociation constants, optical rotation, UV
• · Mechanism of action and therapeutic use
• · Hazard and toxicity information
• · Marketing status information
• · Concise bibliography
• · 1500 Monographs from the PDR® (Physician's Desk Reference) Generics™
• · Extensive documentation describing major drug types and their mechanism of action

System requirements: Pentium II processor or higher, 32 MB Ram, 40 MB hard disk space, 24x speed CD-ROM drive, SVGA monitor at 800x600, 256 colours, Windows® 98, NT 4.x, 2000 or XP. ISBN: 0412787601. List Price: $1,595.00

Metabonomics in Toxicity Assessment. Donald G Robertson Pfizer Global Research & Development, John Lindon Imperial College London, Jeremy K Nicholson Imperial College London & Elaine Holmes Imperial College London. Publication Date: 3/1/2005. Providing essential tools for the toxicologist utilizing metabonomic technologies, this guide presents a clear outline of the use of metabonomics in the safety assessment of new chemical entities; includes equipment and logistical considerations for conducting metabonomic studies from both analytical and biologic perspectives; offers an abundance of figures and tables throughout the text for clear layout of key topics; contains a large amount of references for further research on the topic; presents numerous examples of a wide array of target organs; furnishes in-depth discussions of confounding physiologic variables; covers environmental applications of metabonomic technology; analyzes NMR equipment and instrumentation important to functional metabonomics laboratories. Filling a gap in the literature, this reference provides comprehensive coverage of all aspects of metabonomics technology including analytical and biologic considerations, as well as sections on chemometrics-devoting entire chapters to critical topics such as biomarkers, metabolite identification, and the use of magic angle spinning for tissue metabonomics. Number of Pages: 536.ISBN: 0824726650 List Price: $199.95

Drug Delivery to the Oral Cavity: Molecules to Market. Tapash K Ghosh The Food and Drug Administration, Rockville, Maryland, USA & William Pfister Robbinsville, New Jersey, USA. Series: Drugs and the Pharmaceutical Sciences Volume: 145. Publication Date: 2/28/2005. Emphasizing the impact of intraoral drug delivery and its advantages over conventional oral dosage forms, this handbook covers the latest research concerning drug delivery to the oral cavity, and examines the basic structure, function, biochemistry, and permeability of the oral cavity; analyzes the unique features and optimization of various intraoral drug delivery systems; studies quick, slow, and nondissolving intraoral dosage forms; explores practical and applied aspects of pharmaceutical development for new solid-stage dosage forms for intraoral drug delivery; highlights dozens of oral mucosal delivery systems targeted at the personal care market including quick dissolving films and dentifrice products containing antibacterial agents, fluoride, and flavoring agents; provides a comprehensive appendix of various companies developing intraoral dosage forms and novel delivery system technologies; offers a detailed overview of the wide array of currently available intraoral drug products for the treatment of systemic diseases, as well as products for local treatment of halitosis, bacterial infections, periodontal disease, and other conditions of the mouth; provides an in-depth discussion of recently commercialized drug products for angina pectoris, moderate to severe pain, and smoking addiction. With contributions from recognized authorities in industry, academia, and government, this reference presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market. Number of Pages: 448. ISBN: 0824782933. List Price: $189.95

FDA Administrative Enforcement Manual. Florence R Parker Drug Regulatory Affairs Institute, Pennsylvania, USA. Publication Date: 2/18/2005. Discusses the FDA Administrative Enforcement's authority, detailing what they can and cannot do; Explores the options firms have when faced with FDA Administrative Enforcement actions; Includes case studies to illustrate the 10 FDA enforcement areas and actions; Contains examples of real enforcement letters, injunctions, consent decrees, and other examples of FDA enforcement activities; Delineates practical, hands-on methods to resolve diversified pharmaceutical problems; Presents single-source coverage of all regulated areas cGMP, GCP, GLP, advertising and promotional literature and FDA Administrative Enforcement avenues.

When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought. Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them.

The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities. Number of Pages: 480. ISBN: 084933067X. List Price: $169.95

Encyclopedic Reference of Immunotoxicology. Vohr, Hans-Werner (Ed.). Due 2005. This work provides rapid access to focused information on topics of Immunotoxicology not only for scientists and those dealing with laboratory aspects but also for lecturers and advanced students. Over 200 contributing authors – including many of the world’s top specialists – have contributed full essays on all relevant topics, supplemented by keyword definitions of related terms. Full essays are structured uniformly to provide reader-friendly information on all aspects of Immunotoxicology, including methods of testing and analysis, characteristics of substances, the regulatory environment and the relevance of these to humans. The single A–Z format of both types of entry makes this reference book very easy to use. The complimentary complete CD-ROM version provides additional search facilities. The Encyclopedic Reference of Immunotoxicology is intended to be a comprehensive work of reference which will provide easy access to relevant information in the fast-growing field of Immunotoxicology. Approx. 900 p. 200 illus. With CD-ROM., Hardcover. ISBN: 3-540-44172-7. $299.00

Applying Genomic and Proteomic Microarray Technology in Drug Discovery. Robert S Matson. 12/2004

• Serves as a basic reference for users of microarray technology in drug discovery
• Highlights important scientific work conducted using microarray technology
• Provides direction and practical tips to the reader in working with microarrays
• Includes drawbacks of technology to help readers avoid unnecessary pitfalls

Microarray technology, more commonly known as small spots, has proved a success when employed in DNA array-based genomic analysis. It is now beginning to be employed in protein tissue array analysis; and as microarray continues to be adopted, it is important that researchers grasp the fundamental principles behind it, as well as, the strengths and limitations. This highly informative book written by a leader in the field introduces the fundamentals of microarray technology, then goes on to describe and evaluate the use of microarray technology in genomic and proteomic applications, and provide practical tips on how to employ the technology in drug discovery and development. 256 pp. ISBN: 0849314690.  List Price: $149.95

Analytical Techniques for Biopharmaceutical Development. Roberto Rodriguez-Diaz, Tim Wehr & Stephen Tuck. February 2005. Examining methods to ensure the purity, potency, quality, and performance of drug compounds, this handbook provides

• clear and concise descriptions of various techniques for protein analysis
• organizes chapters according to the order in which one might encounter the methods in the biopharmaceutical cycle
• describes the advantages and limitations of each analytical technique and identifies the most appropriate stage of application during the drug development process
• assesses each method discussed for its efficacy in characterizing the performance, primary sequence, conformation, post-translational modification, stability, degradation, and metabolism of various protein-based pharmaceuticals

This reference assists scientists in the selection and application of analytical techniques for biopharmaceutical identification, formulation, and assessment-providing a valuable survey of exploratory methods commonly utilized during the preclinical, clinical, and commercial phases of development. Number of Pages: 412 pp. ISBN: 0824726677.  List Price: $199.95

Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids. Ram I Mahato. 12/2004.

• Combines an overview of the principles of polymer science and chemistry with the basic biology required to understand how biomaterials can be used as drug-delivery vehicles
• Goes beyond simple discussion of polymers to include information on their design and synthesis
• Includes information on biocompatibility, which is essential for understanding polymeric delivery of drugs
• Features contributions from leading experts in polymer science and drug delivery worldwide

Newcomers to the field of biopharmaceuticals require an understanding of the basic principles and underlying methodology involved in developing protein- and nucleic acid-based therapies for genetic and acquired diseases. Biomaterials for Delivery and Targeting of Proteins and Nucleic Acids introduces the principles of polymer science and chemistry, as well as the basic biology required for understanding how biomaterials can be used as drug-delivery vehicles. No book to date combines a discussion of high-tech biomaterials-based delivery of protein and nucleic acid drugs with the pharmaceutical or biocompatibility aspects. Featuring contributions from leading experts from around the world, this text discusses physiochemical parameters used for design, development, and evaluation of biotechnological dosage forms for delivery of proteins, peptides, oligonucleotides, and genes. The authors also present biological barriers to extravasation and cellular uptake of proteins and nucleic acids. Combining an introduction to biomaterial delivery with the latest developments in the field, this is a valuable reference for both the novice student and the practicing scientist on delivery of biomaterials, on biomedical polymers, and on polymer therapeutics. Understanding these core fundamentals is critical to moving on to more advanced study. 712 pp. ISBN: 0849323347.  List Price: $189.95

Calibration in the Pharmaceutical Laboratory.
Tony Kowalski. 2001. 
Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry. The regulation of test and measuring equipment changes continually as new regulations are introduced and new equipment is developed. Calibration in the Pharmaceutical Laboratory provides general background on laboratory balances and precision scales, insight into mass measurements and associated errors, and detailed information on key quality issues associated with weighing. Managers responsible for QC and QA will find this book an invaluable tool when setting out SOPs for balances and scales used throughout the manufacturing and testing process. Key Features: Provides insight into mass measurement and associated errors • Explains how to establish an acceptable level of confidence in the test and measuring equipment being used • Surveys current good practice in software engineering and relates this practice to application involving scientific instruments • Contains detailed information on key quality related issues • Includes contributions from international experts in the field • Presents the latest GLP/GMP/ISO 9000 standards. 336 pp. ISBN 1574910922  $229.95

Cell Adhesion. Series : Handbook of Experimental Pharmacology , Vol. 165. Behrens, Jürgen; Nelson, W. James (Eds.)2005. This book provides an overview of the main topics of current cell adhesion research including structural analyses of cell adhesion molecules and studies to their functional role in vitro and in vivo. The present volume focuses on the four major families of cell-adhesion receptors, i.e. the cadherins, the integrins, the Ig-superfamily and the selectin-based adhesion system which are discussed in detail by numerous experts in the field. Keywords: Cadherins, Cell adhesion,Ig superfamily, Integrins, Signaling. X, 481 p. 59 illus., Hardcover. ISBN: 3-540-20941-7. $389.00

21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry.
Orlando Lopez . due Jan 2004.
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. The author introduces appropriate supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. The material is presented through practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements. Key Features: Provides a practical approach to computer systems implementation and operational life project management including activities relevant to compliance with Part 11 •  Presents computer validation within the context of regulated operations • Discusses regulatory requirements and furnishes the foundation of the computer systems validation approach • Includes practical examples of applying regulatory requirements • Covers training, security, user or data authentication, and access control. 264 pp.
ISBN 084932243X  $179.95

Cleanroom Microbiology for the Non-Microbiologist, Second Edition. David M Carlberg. 10/2004.

• Covers growth and detection of microorganisms and discusses methods for controlling bacterial growth
• Provides an easy to use introduction to the basic vocabulary of microbiology
• Includes coverage of facilities and personnel control methods
• Describes the common types of microorganisms encountered in the cleanroom, their roles in human activities, and the techniques used to study them
• Explains the rationales behind many of the regulations and operational procedures associated with biocleanrooms

Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist, Second Edition introduces principles of microbiology. It explains the consequences of microbiological contamination, what contamination is all about, how microorganisms grow, and how they can be controlled. The author introduces the vocabulary of microbiology and the types, sources, control, and elimination of organisms encountered in the manufacture of sterile products. Beginning with a discussion of the various types of organisms, the text then covers applications for bacterial detection, avoidance of contamination, cleanroom design considerations, and validation of disinfection methods.

New topics covered include:
· International cleanroom standards
· Application of rapid, automated methods for detecting and identifying microbial contaminants
· In-depth examination of the role of biofilms in pure water systems
· Increased coverage of production of therapeutic products derived from live tissues and cells

Number of Pages: 216 pp. ISBN: 084931996X.  List Price: $139.95

Clinical Studies Management: A Practical Guide to Success.
Simon Cook et al. due Jan 2004. 
This comprehensive desk reference provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. With a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training, this guide is a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Chapters include the R&D process, CROs, the Clinical Study Team, and QA audits. The book presents true-life case histories as well as a comprehensive overview of drug development processes and trends that are driving change. It is a resource for anyone who wishes to sharpen their study management skills. Key Features: Covers the principles of Good Clinical Practice Guidelines • Integrates R&D into the clinical study sequence and models how to write a study protocol • Offers anecdotal and visual examples with easy-to-remember reference points • Presents a comprehensive overview of the drug development process and the trends that are driving change • Includes analysis of interactions between sponsors and CROs as well as a profile of the ideal project manager • Presents stand-alone chapters on key topics. 128 pp.
ISBN 0849320844  $119.95
 

The Combined Chemical Dictionary On CD-ROM.
John Buckingham. 2000. 
Users can now perform convenient time-saving searches across six dictionaries as a single database. Spanning the breadth of chemistry, more than 489,000 compounds contained in over 197,000 entries can be accessed in seconds with powerful searching by text, substructure, or a combination of both. Key Features: Streamlined new interface enabling simultaneous text and structure searching • New customizable report formats giving you the data you need, the way you want to see it • Updated every 6 months • Superb quality onscreen display of text and chemical structures • Available as a single-user or network version. The Combined Chemical Dictionary on CD-ROM provides all entries formerly available on one or more of the following discs: Dictionary of Organic Compounds (246,000 compounds); Dictionary of Natural Products (177,000 compounds); PharmaSource (38,000 compounds); Dictionary of Inorganic and Organometallic Compounds (101,000 compounds); Dictionary of Carbohydrates (20,000 compounds); Dictionary of Analytical Reagents (14,000 compounds). System requirements: Pentium II processor or higher, 32 MB RAM, 40MB hard disk space, 24x speed CD-ROM drive, Windows 95, 98, 2000 (from version 4:2 onwards) or NT 4.x, SVGA monitor at 800x600, 256 colors. 35000 pp.
ISBN  041282020X  $7995.00

Computer Systems Validation.
Quality Assurance, Risk Management, & Regulatory Compliance for Pharmaceutical & Healthcare Companies.
Guy Wingate. Dec 2003.
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture. The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge. Key Features: Contains 24 case studies illustrating the practicalities of validating different types of computer systems supporting laboratories • Discusses GCPs, GLPs, GMPs, GDPs, and Medical Device regulations from around the world, with explanations of the latest regulatory developments from the US FDA • Supplies comprehensive coverage of computer validation principles and how to put them into practice. 1016 pp.
ISBN 0849318718  $499.95.

Dictionary of Commonly Cited Compounds 2001. 
Dictionary of Commonly Cited Compounds on CD-ROM is a carefully edited database containing the 25,000 most frequently cited compounds used by chemists. It contains the top 25,000 most commonly cited compounds in Chemical Abstracts (excluding polymers and biologicals) in Chapman & Hall chemical dictionary format with chemical names, CAS numbers, bibliographic references, physical properties, and chemical structures. Fully substructure searchable, this easy to use database enables rapid retrieval of concise chemical and bibliographic data on the most commonly used chemicals. It covers organic compounds, inorganic compounds, drugs, natural products, materials, alloys, the elements, and their isotopes. Key Features: Streamlined search interface enabling simultaneous text and structure searching • Customizable report formats giving you the data you need, the way you want to see it • Superb quality onscreen display of text and chemical structures· Available as a single user or network version. System requirements: Pentium II processor, running Windows™ 95, 98, 2000, NT4.x, 16MB RAM, 12 MB free hard disk space, 24x CD-ROM drive.
ISBN 1584882514  $84.95

Directory of Approved Biopharmaceutical Products. Stefania Spada & Gary Walsh. 8/27/2004. Provides a brief overview of each biopharmaceutical approved in the US and by centralized European drug approval system in the EU; Outlines the properties of each drug in consistent monograph format; Includes information from both regulatory agencies and pharmaceutical companies; Indexes drugs both by brand name and by biological activity. Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy. Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume. This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference. 336 pp. ISBN: 0415263689. $159.95
 

Drug Delivery Systems. 2nd edition.
Pharmacology & Toxicology series: Basic & Clinical Aspects Volume 4.
Vasant V. Ranade & Mannfred A. Hollinger. 2003. 
Drug delivery technologies represent a vast and vital area of Research and Development. The demand for innovative drug delivery systems continues to grow, and this growth continues to drive new developments. Building on the foundation provided by the first edition, this title covers the latest developments in both industry and academia. Key Features: Covers the latest developments in all areas of drug delivery systems • Presents the information in a simple, straightforward, clear, and concise manner • Provides a global perspective for present and future advances and market opportunities • Contains input from Wall Street and other global financial institutions • Includes strategies for dealing effectively with regulatory agencies around the world. New in this edition: Chapter focusing on novel technologies and their global outlook • Coverage of electronically controlled drug delivery • Macrocapsules and nanoparticles in drug targeting • Drug nanocrystals and other new delivery systems • Updated information on liposomes as carriers. Written in a straightforward, clear, and concise manner, the author provides a global perspective on current and future advances and market opportunities. Drug Delivery Systems, Second Edition answers the need for comprehensive information in a single resource for anyone venturing into this area of drug development. 464 pp.
ISBN 084931433X  $179.95

Drug Discovery and Evaluation. Pharmacological Assays. Vogel, Hans G. (Ed.). 2nd, completely revised, updated, and enlarged ed., 2002. Now expanded and updated to include molecular biology and genetic engineering techniques! The 2nd edition of this successful reference book contains a comprehensive selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Effects covered include cardiovascular, analgesic, endocrine, psychotropic respiratory, renal and immunomodulatory activities. Each of the more than 1000 assays comprises a detailed protocol outlining the purpose and rationale of the method, a critical assessment of the results and their pharmacological and clinical relevance. The enclosed and fully searchable CD-ROM allows easy identification of specific tests. An appendix with up-to-date guidelines and legal regulations for animal experiments in various countries will help the reader to plan experiments more effectively. XLIV, 1408 p. With CD-ROM., Hardcover. ISBN: 3-540-42396-6. $165.00

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164. David Nettleton & Janet Gough. 12/29/2003
" Provides in-depth coverage of CFR 45, and CFR 21 Part 11, and HIPPA regs 160, 162, and 164
" Reproduces relevant section of the regs and provides comment on what they mean in terms of industry standard
" Covers how to evaluate, select, and implement an e-system
" Explores how to establish and maintain security and accountability

The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance. Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act (HIPAA), this book provides guidance for selecting, purchasing, installing, validating, and managing commercial off-the-shelf software for data collection and retention. It takes a number of years for industry standards for a new regulation to develop from dialog between companies and the regulating agency. These standards are in place for Part 11, which was passed into law in 1997. Healthcare providers who must implement electronic record keeping can learn how to best do it by understanding the parallel between the new HIPAA regulations and the industry standards for Part 11. Further, certain FDA-driven activities, such as patient record keeping in clinical trials, now must comply with the new HIPAA regs as well. To help companies achieve and maintain compliance, the authors cover audit trails, validation, documentation, training, and security and accountability. They discuss what the regulations say and what they mean. Compliance may be mandatory, but it also makes good business sense. Companies that are compliant will always be poised to move forward, and they will avoid the grief that comes from poor or faulty record keeping and documentation. This book gives you the tools you need to keep your company both compliant and competitive. 384 pp. ISBN: 0849321646. $299.95

Encyclopedic Reference of Molecular Pharmacology. Offermanns, Stefan; Rosenthal, Walter (Eds.). 2004. This comprehensive encyclopedic reference provides rapid access to focused information on molecular pharmacology for research scientists, clinicians and advanced students. With the A-Z format of about 2000 entries, about 200 authors provide a complete reference to the area of molecular pharmacology. The book combines the knowledge of classic pharmacology describing drug action as well as the more recent approach of the precise analysis of the molecular mechanisms by which drugs exert their effects. Short keyword entries define common acronyms, terms and phrases. In addition, detailed essays provide in-depth information on drugs, cellular processes, molecular targets, techniques, molecular mechanisms and general principles. Each essay is well-structured, with extensive cross-referencing between all entries. The book is accompanied by a CD-ROM which provides the full text and facilitated searches. XXII, 1116 p. 302 illus. 136 tabs. With CD-ROM., Hardcover. ISBN: 3-540-42843-7.$270.00

FDA Administrative Enforcement Manual. Florence R Parker . February 2005.

• Provides the step-by-step process in an FDA administrative enforcement action
• Includes case studies to illustrate the 10 FDA enforcement areas
• Covers pre-clinical, manufacturing, and quality assurance issues

The FDA Administrative Enforcement Manual is a self-contained single source complete with pertinent references and practical outlines for policies and procedures to understand and comply with U.S. drug development and manufacturing regulations. It explores the control of drug research and the manufacturing industry, introduces basic industry experience and techniques, and presents a practicum for applying the theory to everyday problems. The book covers the 10 critical administrative enforcement areas, including recall, application integrity, injunction, seizure, and more, then supplements the topics with regulations, lawsuit case studies, enforcement information, and reference material. 456 pp. ISBN: 084933067X.  List Price: $169.95

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics. Douglas J Pisano & David Mantus. 12/23/2003

" Provides a road map to the FDA and drug, biologic, and medical device development
" Offers current, real time information in a simple and concise format
" Contains a chapter highlighting the new drug application (NDA) process
" Discusses FDA inspection processes and enforcement options
" Includes contributions from experts at companies such as Millennium, Genzyme, leading CROs such PAREXEL, Biologics Consulting Group, and the FDA

Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human drug and device development, research, manufacturing, and marketing. It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, easy to read prose style. It presents information drawn from a wide range of resources in a single, easy to use format. FDA approval can be a lengthy and expensive process. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase procedure must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance under FDA guidelines, this book demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval. 376 pp. ISBN: 1587160072. $149.95

FDA-Speak: A Glossary and Agency Guide.
Dean E. Snyder. 2001. 
Often thought of as a subdialect of American "governmentese," FDA-Speak is a language unique to healthcare regulators and those regulated. If you have any involvement with the US Food and Drug Administration, or if they have involvement with you, you need to speak the language. This revised and updated edition of FDA-Speak retains the original easy-to-use glossary format, but now includes more than three times the number of entries in the first edition, defining more than 2,500 acronyms and technical/regulatory words to which the FDA has applied its own distinctive meaning. FDA-Speak provides the definitive listing of all of the regulatory words, phrases, and acronyms important to development, manufacture, quality control, marketing, import/export, and registration of pharmaceuticals, diagnostic products, medical devices, software, veterinary products, biologics, nutrition and dietary supplements, and bulk chemicals. Don't miss the all-new section of appendices that will guide you to information you need on the FDA website. Appendices include: Laws Enforced by the FDA • FDA Organization Charts and Contact Information • FDA Field Operations Index and Inspection Guides • FDA Forms • FDA Guidance Documents • DSMA Staff Directory. 369 pp.
ISBN 1574911295  $199.95


GMP/ISO Quality Audit Manual for Healthcare Manufacturers and their Suppliers. 6th edition. 
Standardizes audits and minimize subjectivity amongst auditors.
Two volume set: ISBN 0849318491  $499.95
Volume 1: With Checklists and Software Package.
Leonard Steinborn. June 2003.
Provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format. 448 pp.
ISBN 0849318467  $299.95
Volume 2: Regulations, Standards, and Guidelines.
Leonard Steinborn. Nov 2004.
Standardizes audits and minimize subjectivity amongst auditors. Provides easy, objective, and quantifiable results for management track and trend compliance. Assures comprehensive auditing of all facets of applicable regulations and standards. Enables auditors to easily trace checklist questions to the requirements in preparation for closing meetings. Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I. The book is presented in an convenient, easy-to-read format, organized to provide fast access to the guidelines and regulations of interest. 440 pp.
ISBN 0849318475  $299.95

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance. John Sharp. 2004.

• Provides comprehensive coverage of the U.S. and E.U. group requirements
• Presents similarities and differences of each regulation in tabular format for easy comparison
• Offers practical methods, based on experience, for implementation and compliance
• Covers personnel and facilities management as well as manufacturing

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity. 520 pp. ISBN: 0849319943.  List Price: $229.95

Good Design Practices for GMP Pharmaceutical Facilities. Andrew Signore & Terry Jacobs. Series: Drugs and the Pharmaceutical Sciences  Volume: 146. March 2005. This handbook

• spans a wide range of topics central to the successful performance of pharmaceutical oral solid, sterile product, bioprocess, active pharma ingredient, clinical material, and regulated facilities
• contains essential background information and solutions to common challenges in the layout and formation of manufacturing facilities that must comply with current codes, statutes, and regulations in industry
• addresses emerging trends in process technology
• contains practical suggestions that illustrate best practices in the planning and delivery of facilities that perform and conform to current regulatory requirements and business imperatives
• enriches decision-making by emphasizing scope development, master planning, and clear design execution

AUDIENCE: A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces. Number of Pages: 640 pp. ISBN: 0824754638.  List Price: $199.95

Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products (Volume 4 of 6). Sarfaraz K Niazi. 2004.

• Presents the world's largest reference source on pharmaceutical formulations
• Includes readily accessible formulations listed as chemical entities, dosage forms or pharmacological classifications
• Provides instant substantial time and cost-savings in pharmaceutical research and development
• Speeds generic drug formulation regulatory submissions

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products. 288 pp. ISBN: 0849317495. $295.95

Handbook of Pharmaceutical Manufacturing Formulations. by Sarfaraz K Niazi  Therapeutic Proteins Inc., Deerfield, Illinois, USA. 2004.

·  Supplies the largest reference on pharmaceutical formulations
·  Lists readily accessible formulations as chemical entities, dosage forms or pharmacological classifications
·  Provides substantial time and cost savings in pharmaceutical research and development
·  Covers issues related to generic manufacturing of drugs including cGMP compliance, pre-approval inspections, stability testing, and more

With exponential growth of generic formulations, the need for ready formulations has increased. Essentially an authoritative and practical guide to the art and science of formulating drugs, the six-volume handbook contains the Bill of Materials and Manufacturing Directions for over 2000 drug formulations, including a number of biotechnology and patented drugs.

The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications and other sources of generic and proprietary formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations.

Each volume of the series is divided into two parts: the section on regulatory and manufacturing guidelines and the section on formulations. The series covers issues related to generic manufacturing of drugs including cGMP compliance, pre-approval inspections, stability testing, bioequivalence testing, packaging commodity development, changes to aNDAs, SUPAC for equipment, and a large number of other relevant and current topics of interest to the pharmaceutical industry. Each category of drug formulations, classified in separate volumes, is analyzed for the common difficulties in formulating drugs.

This book is the first of its kind published in the pharmaceutical literature and is a must collection for all pharmaceutical manufacturers, educational, and regulatory authorities. Companies with large formulation teams will find this book an excellent platform for benchmarking their own products and generic companies will find this book an excellent source of information prior to embarking on formulating drugs coming off patent. Number of Pages: 2836. ISBN: 0849317525. $1,695.00

International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products. 2nd edition.
Charles Sidebottom. 2003. 
Extensively revised, with an updated title that reflects its expanded scope, International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products, Second Edition provides the practical labeling information you need to achieve rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, the book explains the relevant laws, regulations, and requirements in major markets worldwide. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, OTC products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more. This is not a "cookbook" of easy-to-follow recipes. It is a comprehensive resource that gives you the tools to stay ahead in the ever-changing regulatory environment. Key Features: Helps readers obtain rapid regulatory approval and success in the marketplace • Explains all aspects of advertising, labeling, and packaging in clear, concise language • Provides explanations of the relevant laws, regulations, and requirements in major markets worldwide without excess "governmentese" • Uses examples of compliance and noncompliance to demonstrate the concepts discussed in the text. 616 pp.
ISBN 0849318505  $269.95

Lipospheres in Drug Targets and Delivery: Approaches, Methods, and Applications. Claudio Nastruzzi. 11/29/2004.

• Discusses innovative methods of delivering bioactive substances to different systems
• Presents lipospheres as a technical solution to problems associated with controlled release of drugs
• Covers lipospheres as carriers for vaccines
• Provides procedures for specific applications and biological systems

Lipophilic drug carriers such as lipospheres and lipid nanoparticles can modify the in vivo distribution of associated substances. They can therefore be used to improve the therapeutic index of drugs by increasing their efficacy and/or reducing their toxicity. If the delivery systems are carefully designed, lipospheres can help to overcome the delivery problems posed by new classes of active molecules, such as peptides, proteins, genes, and oligonucleotides. They may also extend the therapeutic potential of established drugs. With these powerful abilities, lipid-based nano- and microparticulate carriers are becoming an increasingly important weapon in the pharmaceutical arsenal. Lipospheres in Drug Targets and Delivery: Approaches, Methods, and Applications presents an overview of the most recent applications of lipid-based nano- and microparticulate carriers in the fields of medicine and biotechnology. It includes chapters on preparation, characterization, and delivery of lipospheres; liposphere based vaccines; therapeutic applications to different systems, and suggestions for further research. With numerous illustrations, tables, and photographs, this book describes procedures for specific applications and biological systems and presents lipospheres as a technical solution to various problems associated with the controlled release of biochemicals. Written for researchers in medicine and life science, pharmaceutics, and biotechnology, this book provides in-depth coverage of an important topic in biochemistry, molecular biology, and drug development. Number of Pages: 184. ISBN: 0849316928. $169.95
 

The Merck Index: CD-ROM Windows, Version 12.3.
S. Budavari, et al. 2000. 
The Merck Index* has been a trusted reference tool for more than a century, and it continues to be the premier resource for science and medical professionals in the new millennium. The need for enhanced resources has never been greater, and this user-friendly CD helps meet the challenges of the future by offering easy access to a vast world of information, -- both quickly and efficiently. Special features include outstanding search capabilities, including the tools to draw the structure you are interested in ON-SCREEN -- and then search for it. Text searching is possible in over 27 fields including: Chemical, Common, Generic Names and Trademarks • Molecular Weights and Formulae • Physical and Toxicity Data • Citations to Scientific and Patent Literature. Key Features: 100 new monographs supplement the more than 10,430 monographs in Version 12:2 • Extensive updates of many original monographs • Streamlined search screens give you faster access to the data you need • Fully customizable report options enable you to print results exactly as you want to see them • Full 32-bit compatibility with Windows NT. 2100 pp.
ISBN 1584881291  $79.95

Microbiological Assay for Pharmaceutical Analysis.
A Rational Approach.
William Hewitt. due Dec 2003. 
A user-friendly guide for the evaluation of microbiological assays, this book provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those sources of error. Beginning with a review of the theoretical basis for the quantitative aspects, the author discusses microbiological assay as a branch of pharmaceutical analysis and distinguishes it from biological assay in general. He draws attention to the microbiological aspects that may not be so obvious to the chemical analyst and to the analytical aspects that may not be so obvious to the microbiologist. The book contains detailed evaluations of assays that illustrate typical experimental designs and addresses how to present a realistic assessment of the best potency estimate from a series of assays. Although there are other valuable books available in this area, they do not address evaluation. It expands on the guidance given in pharmacopoeias and helps you choose the assay design most appropriate for the purpose of your assay. Key Features: Explores how to design an efficient assay that minimizes sources of error • Facilitates real understanding of the validity of an assay rather than just acceptance of the results of a statistical evaluation • Discusses the criteria for making the decision to accept or reject the results of an assay • Covers issues of sensitivity, specificity/selectivity, accuracy, and precision • Illustrates the wide range of experimental designs available to the analyst and compares their properties • Includes inspection techniques from European and United States pharmacopoeias. 260 pp.
ISBN 0849318246  $229.95

Microbiological Contamination Control in Pharmaceutical Clean Rooms.  Nigel Halls. 2004. Discusses measurement and control of contamination for safe drug manufacturing. Offers logical approaches to problems associated with oral and nasal preparations. Reviews the most common commercial rapid microbiological test methods. Features a chapter on clean room finishes and construction materials - information available nowhere else. Highlights microbial focus of clean room control and the importance of knowledgeable laboratory practices . Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisciplinary approach, Microbiological Contamination Control for Pharmaceutical Clean Rooms neatly clarifies some of the perceived problems surrounding contamination control in pharmaceutical industry clean rooms. The book helps you satisfy domestic and international regulations and prevent your organization from suffering the consequences of non-compliance. It includes up-to-date information on microbiological contamination in sterile manufacturing, microbiological media fills, microbiological environmental monitoring, control in aqueous-based, non-sterile pharmaceuticals, rapid testing methods, and clean room contamination control. This valuable guide brings you up to date on the types of techniques available, the scientific principles that underpin them, and the practicalities and limitations of each. Number of Pages: 200. ISBN: 0849323002.  $199.95

Microbial Contamination Control in the Pharmaceutical Industry. Series: Drugs and the Pharmaceutical Sciences Volume: 142. 8/30/2004. Offers comprehensive examination of the literature on the application and implementation of rapid technologies for quality control analysis; Includes chapters by world-renowned authorities on topics including water testing, endotoxins, environmental monitoring, and more. Discusses the limitations of standard analytical methods and the use of alternative technologies to enumerate, detect, and identify microorganisms; Describes and compares the microbiological method and sterility test requirements, pass and fail criteria, and validation procedures of three major pharmacies. Includes examples of suitable quality control programs for water testing; Assesses testing protocols and microorganisms utilized in the validation of disinfectant efficacy; Covers critical factors affecting the preservation of pharmaceutical products. This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions. 328 pp. ISBN: 082475753X. $175.00

Microwave Assisted Organic Chemistry. Jason P Tierney & Pelle Lidstrom. due Fall 2004. Microwave Assisted Organic Chemistry demonstrates the under lying principles of microwave dielectric heating and, by reference to a range of organic reaction types, its effective use in synthetic organic chemistry. The recent introduction of specifically designed and constructed microwave equipment, countering safety, and reproducibility concerns has led to widespread use of microwaves in synthetic organic chemistry. Microwave assisted synthesis is now established in many industrial and academic laboratories giving access to the novel chemistry that can be carried out in a variety of organic reaction types. Case studies, drawn from the pharmaceutical industry, illustrate the impact microwave assisted organic synthesis can have on chemical research.  Number of Pages: 320. ISBN: 0849323711. $149.95

Modern Protein Chemistry: Practical Aspects.
Gary C. Howard & William E. Brown. 2001. 
In recent years, interest in proteins has surged. This resurgence has been driven by the expansion of the post-genomic era when structural genomics and proteomics require new techniques in protein chemistry and new applications of older techniques. Protein chemistry methods are used by nearly every discipline of biomedical research. Many techniques have been used in less traditional ways with exciting results. Modern Protein Chemistry: Practical Aspects describes the practical side of advanced techniques in protein chemistry. The book gives researchers an excellent "cost-benefit" analysis of these techniques. The contributors have been selected for their prominence in their specific fields and because they run laboratories that actively collaborate with other scientists. Researchers and practitioners, both beginners and experienced, who are looking for new ideas and who are interested in applying these more advanced methods will be assisted in their work by these commentaries. This guide provides hands-on information to complement theoretical understanding. The theory behind these methods can be found in existing books and in the original literature. However, no other guide will help you make a practical evaluation of these methods and their value to your work. Key Features: Presents careful descriptions and critiques of techniques for an overview and cost benefit analysis • Describes alternate methods to allow for choice by the researcher • Provides hands-on information to complement theoretical understanding. 272 pp.
ISBN 0849394538  $109.95

Pharmaceutical Product Strategy: Using Dynamic Modeling for Effective Brand Planning. Mark Paich, Corey Peck & Jason J Valant . 12/2004

• Shows interface between marketing, clinical trials, market research and sales force
• Addresses both patients and doctors as audiences
• Discusses the MD adoption process
• Presents various open source databases

Focusing on cross-functional coordination and knowledge integration, Pharmaceutical Product Strategy: Using Dynamic Modeling for Effective Brand Planning introduces many of the complexities facing many pharmaceutical firms. The book examines issues surrounding utilization of information, consistency of assumptions, and the need for processes that integrate various functional areas. It also discusses why the dynamic modeling process is an effective way to address these problems in a systematic and accessible way. An appendix covers more technical points of dynamic model analysis including agent-based approaches and mathematics of continuous formulations, and details for choice models and conjoint analysis. 328 pp. ISBN: 0849327296.  List Price: $159.95

Pharmaceutical Engineering Change Control. 2nd edition.
Simon G. Turner. due Dec 2003.
While change control can ensure that developments do not compromise business operations, when dealing with pharmaceuticals manufacturing, change control must also ensure that developments do not compromise regulatory compliance. This title gives you the technical and management skills required to successfully and efficiently employ change control procedures. Key Features: Examines the basis for developing change control procedures for pharmaceutical projects • Discusses the importance of integrating change control into quality management systems • Explores the role computers play in the production of pharmaceuticals • Covers how to ensure change controls are effectively applied and recorded • Contains case histories that illustrate key points and provide a basis for change control training. 168 pp.
ISBN 0849320615  $189.95

Pharmaceutical Marketing: A Practical Guide.
Dimitris Dogramatzis. 2001. 
Designed as a practical guide for the pharmaceutical industry, this book applies cutting-edge marketing concepts and tools to the real-world intricacies of marketing a heavily regulated product whose success is determined not by the actual end-user, but by various industry stakeholders. From creating a worldwide vision that cascades into local tactics to managing a drug portfolio or pricing a particular product, this book guides readers through developing, implementing, and auditing a successful marketing strategy geared specifically to the pharmaceutical industry. It provides graphs, tables, sample worksheets, pharmaceutical case studies, and a sample marketing strategy. 400 pp.
ISBN 157491118X  $249.95

Photostability Of Drugs And Drug Formulations, 2nd Edition. Hanne Hjorth Tonnesen.  2004. Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features: " Assists non-experts in this field design a test protocol and interpret the results " Covers in vitro and in vivo aspects of interactions between drugs and light " Explores the kinetic and chemical aspects of drug photodecomposition " Discusses the problems frequently encountered in photochemical stability testing " Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs " Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint " Offers specific guidance in photostability testing and screening of drug photoreactivity. Number of Pages: 448. ISBN: 0415303230. $189.95

Polymeric Gene Delivery: Principles and Applications. Mansoor M Amiji Northeastern University, Boston, Massachusetts, USA. 9/29/2004. Describes the different delivery options with polymeric materials; Addresses various challenges to gene delivery using polymeric vehicles; Provides perspectives from both academic research labs and industrial applications. To treat disease or correct genetic disorders using gene therapy, the most suitable vehicle must be able to deliver genes to the appropriate tissues and cells in the body in a specific as well as safe and effective manner. While viruses are the most popular vehicles to date, their disadvantages include toxicity, limited size of genes they can carry, and limited scale of industrial production. This is the first comprehensive book to specifically address polymeric gene delivery systems. Uniting the expertise of international academic and industrial scientists who are working in the area of polymeric vectors for gene delivery, it is written by prominent researchers directly involved in this field. The book is divided into five sections that deal with challenges and opportunities in gene delivery and the efficient delivery of genes into somatic cells using polymeric vectors. The authors discuss using biodegradable polymers, condensing and non-condensing polymeric systems, microspheres and nanospheres, and designing specialized delivery systems based on targeting strategies. This book accentuates the versatility of polymeric delivery systems, including the potential for biocompatibility, the ability to design their formulation and geometry for a specific purpose, and the ease of modification to the surface of polymeric carriers. This book is an up-to-date guide for researchers in the field and those interested in entering this dynamic field. Number of Pages: 704 pp. ISBN: 084931934X. $179.95

Polysaccharides: Structural Diversity and Functional Versatility, Second Edition. Severian Dumitriu. 11/2004

• Discusses renewable resources for the production of various industrial chemicals and engineering plastics polysaccharides
• Covers new developments in cellulose technology
• Offers methods to optimize and control polysaccharide properties and produce new materials with improved performance

Completely revised and expanded to reflect the latest advancements in the field, Polysaccharides, Second Edition outlines fundamental concepts in the structure, function, chemistry, and stability of polysaccharides and reveals new analytical techniques and applications currently impacting the cosmetic, medicinal, chemical, and biochemical industries. The authoritative book discusses polysaccharides utilized in medical applications such as polysaccharide-based hydrogels, polysialic acids, proteoglycans, glycolipids, and anticoagulant polysaccharides; renewable resources for the production of various industrial chemicals and engineering plastics polysaccharides; and more. 1224 pp. ISBN: 0824754808. $269.95

Practical Pharmaceutical Laboratory Automation.
Brian Bissett. due 2004. 
Laboratory automation is an increasingly important part of the job description of many laboratory scientists. Although many laboratory scientists understand the methods and principles involved in automation, most lack the necessary engineering and programming skills needed to successfully automate or interface equipment in the lab. A step-by-step, how-to reference and guide, Practical Pharmaceutical Laboratory Automation explores the processes needed to automate the majority of tasks required in research today. The author discusses topics ranging from automated mathematical analysis to robotic automation of chemical processes, to combinations of these and other processes. He presents a detailed discussion of high throughput screening and assay development and takes an in-depth look at Visual Basic as the primary programming language used in laboratories. The text has a dedicated web site (http://www.pharmalabauto.com) which contains all the sample code and examples contained within the text as well as other information related to laboratory automation. Providing a starting point for tackling automation problems, Practical Pharmaceutical Laboratory Automation helps you develop a strategy for automation that gets consistent results. Key Features: Provides information that can be used to construct simple, low cost, automatic test systems • Discusses high throughput screenings (HTS) and assay development Includes practical examples and solutions to real world problems that are hard to find in other sources • Explores the concepts and methods of reverse engineering • Helps you set up systems to measure a variety of quantities Provides a Web site with companion files to the text at http://www.pharmalabauto.com/. 464 pp.
ISBN 0849318149  $189.95  
 

Preventing Medication Errors and Improving Drug Therapy Outcomes.
A Management Systems Approach.
Charles D. Hepler & Richard Segal. 2003. 
Drug-related illnesses and complications cost the health care system billions of dollars each year. Medical errors account for approximately 100,000 deaths each year, and drugs are the most common cause of medical errors in hospitals. Synthesizing research studies from seven nations, Preventing Medication Errors and Improving Drug Therapy Outcomes: A Management Systems Approach explores medications use from a social perspective. It identifies and describes the preventable adverse outcomes of drug therapy, discusses the safety, cost-effectiveness, and quality of medications use from a management systems perspective, and proposes systematic solutions. Key Features: Discusses drug therapy and medications use from a comprehensive, systems perspective • Synthesizes selected research from seven countries on adverse outcomes from the use of medications • Describes what a properly designed and managed drug therapy system would look like and how the components should fit together • Covers processes for evaluating medication-use systems and identifying and correcting ineffective system operations • Presents detailed data on patient outcomes and why standards must change to improve drug safety and effectiveness. Read this book in order to learn: Why medicines often fail to produce the desired result and how such failures can be avoided • How to think about drug product safety and effectiveness • How the main participants in a medications use system can improve outcomes and how professional and personal values, attitudes, and ethical reasoning fit into drug therapy • What a properly designed and managed medications use system would look like - specific components, how the components fit together into a system, and how the system can be maintained and improved • Ways to evaluate medications use systems, how to recognize ineffective systems operations, how to identify missing system components and how to correct them •  How the environment of medications use affects systems operations and patient outcomes, and why standards must change to improve drug safety and effectiveness. 464 pp.
ISBN 084931576X  $149.95
 

Rapid Microbiological Methods in the Pharmaceutical Industry.
Martin Easter & Tom Novitsky. March 2003. 
In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond? Rapid Microbiological Methods in the Pharmaceutical Industry answers these questions and more. Key Features: Provides the details of a range of rapid microbiological methods, their applications, and practical tips regarding validation, established use, and regulatory acceptance • Brings together expert opinion and experience in implementing microbiological methods and their application in the pharmaceutical industry • Covers the origins of methods and current issues facing the requirements of microbiology and its associated test methods • Explores how to seek better, more pragmatic methods for the assessment of microbiological hazards and risks to ensure product and consumer safety. Martin Easter and his panel of experts: Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance • Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods • Delineate the challenges involved in seeking better and more pragmatic methods for the assessment of microbial hazards and risks to ensure product and consumer safety. The book assists you in applying an effective system to assess the real microbiological hazards and, hence, quantify realistic risks. Additionally, it provides monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. The expert and authoritative information in this book will help you find better solutions to ensuring the microbiological safety of pharmaceutical products. 288 pp.
ISBN 1574911414  $239.95  


Safety Pharmacology in Pharmaceutical Development and Approval.
Shayne C. Gad. 2003.
The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Conference on Harmonization (ICH) guidelines, safety pharmacology will become a more important phase in drug development. Safety Pharmacology in Pharmaceutical Development and Approval spells out the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery. Until recently, pharmacovigilance has been product-rather than utilization-oriented and often invisible in clinical medicine. It is clear that definitive safety pharmacology standards are needed to combat the increase in adverse reactions seen in the last 20 years. Giving you a head start in this emerging field, Safety Pharmacology in Pharmaceutical Development and Approval addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations. Key Features: Presents international perspectives including the activities of the International Conference on Harmonization • Explains how to integrate safety pharmacology evaluations into existing safety evaluation studies • Covers the core battery of tests and supplemental testing procedures • Discusses the principles of safety pharmacology study design and interpretation and their relevance to man • Provides detailed coverage of this emerging discipline. 208 pp.
ISBN 0849313805  $149.95

Software Development and Quality Assurance for the Healthcare Manufacturing Industries. 3rd edition.
Steven R. Mallory. 2002.
Completely revised and updated, this book is a practical guide for anyone involved in all levels of the development and quality assurance of software programs for healthcare products - particularly in the medical device and equipment manufacturing industries. From high-level strategies and mechanics to detailed flow charts, tables, and sample forms, the text helps assure that all requisite phases of development and testing have been considered and implemented as readers develop a complete, integrated, cohesive, and interrelated software quality assurance program. Readers will learn how to design, implement, and manage the software development effort, as well as how to audit the program. 532 pp. 
ISBN 1574911368  $239.95

Springer Index of Viruses. Tidona, Christian A.; Darai, Gholamreza (Eds.)2001. This comprehensive Encyclopedic Reference systematically integrates the state-of-the-art knowledge on all virus genera in the standardized format of lists, tables and figures. Each chapter provides highly structured and condensed information on a single virus genus and was contributed by one of the worlds leading experts in that particular field. Each of the 241 taxonomically ordered chapters includes detailed information on individual genus members, historical events, virion morphology, genome properties, replication strategy, properties of individual transcripts and proteins, sequence accession numbers, biological properties, diseases, recombinant vector constructs, vaccine strains, key references, as well as a high-resolution particle image and a drawing of the genome organization. Its high content of easily accessible detail information makes this Encyclopedic Reference an indispensable tool for both researchers and lecturers. XLVII, 1511 pp. 434 figs., 1449 tabs., with CD-ROM., Hardcover. ISBN: 3-540-67167-6. $325.00

Transcription Factors. With contributions by numerous experts. Series : Handbook of Experimental Pharmacology, Vol. 166. Gossen, Manfred; Kaufmann, Jörg; Triezenberg, Steven J. (Eds.). 2004. The present volume, authored by leading experts in the field, contains in-depth information regarding the role of transcription factors as key players in the execution of the genomic program of any given cell. Many of the chapters focus on the role of transcription factors in cellular transformation and cancer, other chapters highlight the contributions of transcription factors to inflammatory responses or xenobiotic responses. Moreover, the volume illustrates how a viral transcription factor interferes with the physiology of its host cell and finally points out how much exciting research transcription factor biology still has to offer. X, 581 p. 72 illus., Hardcover. ISBN: 3-540-21095-4. $399.00

Textbook of Receptor Pharmacology. 2nd edition.
John C Foreman & Torben Johansen. 2002.
The bestselling first edition of Textbook of Receptor Pharmacology originated from a renowned course in receptor pharmacology taught at the University College of London for the past three decades. Its innovative format united four major approaches to the study of receptors: molecular biology, quantitative functional studies of agonists and antagonists, ligand binding, and signal transduction systems. The second edition builds on this foundation. This edition streamlines the material and focuses on cell membrane receptors along with their immediate signal transducers. The section on the molecular structure of receptors reflects the advances in this area. This edition also includes two restructured new chapters, one on G-proteins and one on tyrosine kinases, as signal transductors. Several chapters also contain problems for students to solve as well as worked-out solutions. The book contains over one hundred useful diagrams and tables to aid illustration of concepts and a helpful appendix explaining the simple mathematics used in the text. A time-saving resource and comprehensive textbook, Textbook of Receptor Pharmacology, Second Edition provides in-depth, up-to-date coverage of this still rapidly expanding research area that is both fundamental to the science of pharmacology and on the cutting edge of new drug development. Key Features: Contains two new chapters: Molecular Structure of Tyrosine Kinase Receptors and G-Proteins • Provides over a hundred diagrams and tables to aid illustration of concepts, practice problems to facilitate comprehension, and an index explaining the simple mathematics used in the text • Unites four major approaches in the study of receptors: molecular biology, quantitative functional studies of agonists and antagonists, ligand binding, and signal transduction systems • Includes an overview of the importance of receptors in drug development written by Nobel Laureate James W. Black • Constructs a logical introduction to the various approaches that can be taken to the study of drug receptors • Presents information from an international group of experts. 304 pp.
ISBN 0849310296  $99.95

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