Balogh International Inc., Blue List, Defect Evaluation Lists, EC Guide to Good Manufacturing Practice for Medicinal Products, European Genetic Engineering Law, Fiedler Encyclopedia of Excipients for Pharmaceuticals Cosmetics and Related Areas, German Dru

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GCP Auditing. Methods and Experiences. Presented by an Expert Group of the German Society for Good Research Practice,. 2nd revised edition. 2007. Due to the ”Good Clinical Practice” (GCP) requirements the high demands of quality assurance internationally became an integral part in the conduct of clinical trials. The conducting of audits enables pharmaceutical companies, CROs, authorities etc. to verify whether the required standards are complied with. The methods used for the planning, conducting and evaluation of auditing measures are presented in detail. Thus this textbook provides the necessary material for both the audits as such and for their evaluation. Different fields of work are presented – investigator, clinic, laboratory and CROs. The subjects dealt with include the trial protocol, information for study participants, computer system validation, validation in clinical studies employing electronic data capture systems, audit schedule and audit report. The authors (members of a board of experts of the Deutsche Gesellschaft für Gute Forschungspraxis, DGGF; German Society for Good Research Practice) work in the pharmaceutical industry or at CROs and have had many years of experience in the quality assurance field. 192 pp. ISBN 10: 3-87193-356-2; ISBN 13: 978-3-87193-356-1. $110.00

Pulmonary Drug Delivery. Basics, Applications and Opportunities for Small Molecules and Biopharmaceutics. author: K. Bechtold-Peters, H. Luessen. 2007
Pulmonary drug delivery is an innovative dosage form with a wide spectrum of use. It certainly has a great future providing new and more patient-friendly therapeutic drug delivery systems for the application of insulins, antiasthmatics/ broncholytics and other appropriate active pharmaceutical ingredients. Summarizing the current state of knowledge in respect of pulmonary drug delivery, the book deals with the physiological basis, addresses issues concerning pharmaceutical technology and production and the clinical and practical application of new dosage forms. Further discussed are some important aspects of analysis and regulatory questions. 412 pp. ISBN 10: 3-87193-322-8; ISBN 13: 978-3-87193-322-6. $202.00

Fiedler - Encyclopedia of Excipients. Hoepfner, Eva-Marie; Lang, Siegfried; Reng, Alwin; Schmidt, Peter Christian. 2007. 6th ed. More than 12,900 new and revised excipients arranged according to pharmacopoeia title, INCI, INN, CAS, chemical name and synonyms, formula, etc, preparation, properties, product data, applications, toxicology (with an actual overview of pharmacological and toxicological properties and allergy-induing reactions and FDA status), analytics, references (reviews up to 2005), single products of groups of substances. Encyclopedic entries give a base and overview with general descriptions of raw materials (e.g. Butane, lactose), of substance classes (e.g. eye preparations, moisturizers, plasticizers, tablet excipients), abbreviations of important names and institutions (EINECS). Also has a completely revised manufacturers list with more than 400 firms and websites and current products. A new and revised survey tables for international use with a separate sections for cosmetic ingredients review (CIR), coloring agents for cosmetics and drugs, dangerous substances, food additives, preservatives, sieves, solubilizers, surfactants, etc. 1600 pp. hardcover. 2 volumes. ISBN: 3-87193-346-5. $595.00; CDROM version: ISBN 3-87193-347-3. $595.00; print+ online 3-87193-345-7 $935.00

Guide to Drug Regulatory Affairs. B. Friese, B. Jentges, U. Muazzam und Beiträgen von T. A. Keller, C. Oldenhof, K. Olejniczak, H. Potthast, Joachim A. Schwarz, B. Sickmueller. 2007. This is the first comprehensive overview of the legal and regulatory framework for marketing authorisation applications in Europe, including Switzerland. It gives extensive and valuable advice on how to compile a marketing authorisation according to the CTD format (Modules 1 – 5 CTD). The ’Guide’ has been developed to penetrate the ’regulatory jungle’ and make related work much easier and more efficient. With both a printed and a regularly updated online edition, the ‘Guide’ is a multi-media platform designed to support the different needs of its many users.

The ’Guide’ is subdivided into four major parts

Part A: This provides detailed information about different procedures for drug approval, and relevant legislation and requirements that have to be considered when submitting an application for marketing authorisation. Judicial decisions from pertinent European courts are also highlighted.
Part B: This gives detailed practical advice on how to prepare an application for marketing authorisation and also the accompanying documents which demonstrate quality, safety and efficacy. In addition, aspects of maintaining the marketing authorisation are discussed, covering applications for variations to a marketing authorisation, extension applications and renewal applications. Regulatory compliance issues are considered, and the requirements for IMPDs (Investigational Medicinal Product Dossiers) are included. Marketing authorisation procedures and the regional part of a Swiss marketing authorisation application are also considered.
Part C: This describes the main provisions relevant to biopharmaceuticals, plant-based traditional medicinal products, blood, blood products and orphan drugs.
Part D: This includes much additional helpful information: an index of abbreviations, an index of terms and definitions, literature, links etc.

Available as a print or online edition, the ‘Guide’ is a multi-media resource designed to support the different needs of its users.
Contents – The print edition with more than 800 pages is primarily intended as an invaluable reference-book.

The key benefits of the constantly updated, user friendly and easily navigated online edition include:
- Multiple search options, such as full-text, chapters, terms and keywords
- Constant updates and amendments
- Comments and interpretation of EMEA and EU news and documents
- Instant access to all relevant official documents
- Direct link to EU and EFTA authorities
- Permanent link check to nearly 700 links mentioned in the Guide
- Discussion Forum
- Regular Newsletter
- Link to upcoming events including conferences and education courses in the field of Drug Regulatory Affairs
- Job Market
Target groups:
- Employees, Executives and Directors of Pharmaceutical Companies and the API Industry (API Active Pharmaceutical Ingredients)
- Legal Advisers and Attorneys
- Employees and Heads of Regulatory Authorities
- Consultants
- Professionals in Quality Assurance
- Training in Regulatory Affairs
ISBN 3-87193-324-4. hardcover. $325.00

Peptidomics in drug development. D. Gänshirt, F. Harms, S. Rohmann, P. Schulz-Knappe. 2005. Peptidomics is used in a wide and growing range of applications in academia, biotech, and pharmaceutical industry. Being driven by innovative technologies, this novel field utilises the information from genomic data to describe disease states and molecular mechanisms of drug action by analyzing the multitude of peptides in living systems. It is already clear that peptidomics is ideally suited for biomarker discovery. The precise diagnosis and personalized treatment of disease is the vision that motivates researchers to enter peptidomics. In this book the peptidomics pioneer BioVisionN gives insight into its unique technologies of differential display analysis of peptides and illustrates appropriate bioinformatics- and data mining tools. They also describe some of the most prominent medical applications of this rapidly emerging technology in CNS diseases, cancer, and diabetes. In addition the Health Care Competence Center – HC3, a specialist for innovative health care strategies, highlights the role and future perspectives of peptidomics in drug development as determined in a global primary data evaluation in the pharmaceutical industry. 152 pp, hardcover. ISBN: 3-87193-323-6. $134.00

ROTE LISTE® Book 2005. Arzneimittelverzeichnis für Deutschland (einschließlich EU-Zulassungen). author: Rote Liste® Service GmbH. language: German. edition / year of publication: 2005. ROTE LISTE® enables the user to compare drugs from a pharmacological-therapeutic view. The compendium is arranged by areas of therapy and substance classes. The drugs having marketing authorization in Germany and EU-wide are summarized in 88 major groups. Continuously updated and concise information about pharmaceu-tical and pharmacological-therapeutic properties. These informative details make ROTE LISTE® a standard reference of unchanged value for the prescribing physician and for pharmacists. For drugs subject to the fixed-price scheme the fixed price is indicated in addition to the pharmacy selling price.

- 8933 drug entries
- 11423 preparations
- 35063 price indications
- 493 companies

extent: 2128 pages;m format, cover: DIN A4, hard plastic cover; ISBN: 3-87193-306-6. $115.20; CDROM also available at the same price

Blue List.
Cosmetic Ingredients.
F.L.H. Kemper, N.-P. Luepke and W. Umbach. 2001.
This reference book has been newly compiled based on the previous list "Blaue Liste." It considers all ingredients of cosmetic products listed in an inventory based on the EC Cosmetic Directive including inactive ingredients with their INCI names (International Nomenclature Cosmetic Ingredients), i.e. 8000 substances with more than 150.000 entries. Additionally approximately 1000 substances are listed in an "Annex" for which meanwhile also an INCI name has been proposed by COLIPA (Comité de Liaison des Associations Européennes de l'Industrie de la Parfumerie, des Produits Cosmétiques et de Toilette). Directory of cosmetic ingredients with instructions for use in English, German and French. Entries in English. Considering European legislation. Hardcover book with CD-ROM, 880 pp. CD-ROM for Windows 3.11/95/98/2000/NT.
ISBN 3 87193 239 6 $286.00

Defect Evaluation Lists (printed in German and English)

►Vol. 12: General Principles. Allgemeine Grundlagen. Brüggemann et al. 2004. Paperback, 136 pp. CD-ROM inclusive. ISBN 10: 3-87193-305-8; ISBN 13: 978-3-87193-305-9. $130.00

NEW! ►Vol. 13: Secondary packaging materials (printed and non-printed). with CDROM new 5th edition 2009. S. Harl & W. Stolze. 2009 . Paperback, 132 pp. ISBN 9783871933776. $143.00

►Vol. 14: Containers Made of Moulded Glass. Behältnisse aus Hüttenglas. Doege & W. Stolze. 2010. Paperback, 106 pp. CD-ROM inclusive. ISBN 978 3 87193 364 6 $143.00

►Vol. 15: Aerosol Cans Made of Metal. Aerosoldosen aus Metall. W. Stolze & H.D. Ruthemann. 1996. Paperback, 92 pp. ISBN 3 87193 171 3 $70.00

►Vol. 17: Injection-moulded Parts Made of Plastic: Boxes, Tubes, Turning and Sliding Mechanism. Spritzgußteile aus Kunststoff: Dosen, Röhren, Schachteln, Dreh- und Schiebemechanismen. H.D. Ruthemann, W. Stolze. 1993. Paperback, 88 pp. ISBN 3 87193 133 0 $70.00

►Vol. 18: Plastic Stoppers, Desiccators and Caps. Kunststoff-Stopfen, Trockenkapseln und Aufsteckkappen. H.D. Ruthemann & W. Stolze. 1995. Paperback, 76 pp. ISBN 3 87193 162 4 $70.00

NEW! ►Vol. 19: Containers Made of Tubular Glass. Behältnisse aus Röhrenglas. F.R. Rimkus & P. Raimann. 2009. new 4th edition! Paperback, 122 pp. CD-ROM inclusive. ISBN 978-3-87193-358-5 $143.00

►Vol. 20: Rubber Parts. Gummiteile. G. Ziegert. 3rd ed. 2007. Paperback, 120 pp. CD-ROM included. ISBN 978-3-87193-366-0 $151.00

►Vol. 21: Valves, Pumps, Adaptors. Ventile, Pumpen, Adapter. H.D. Ruthemann & W. Stolze. 2007. Paperback, 76 pp. plus CDROM. 3-87193-371-6; ISBN 13: 978-3-87193-371-4 . $115.00

FORTHCOMING! ►Vol. 22: Injection-moulded Parts Made of Plastic: Closures, Sealing Disks, Dosage Aids (Droppers, etc.). Spritzgußteile aus Kunststoff: Verschlüsse, Dichteinlagen, Dosierhilfen (Tropfer etc.). R. Theobald & W. Stolze. 2010. Paperback, 80 pp. ISBN 978 3 87193 406 3 $109.00

FORTHCOMING!►Vol. 23: Plastic-moulded Containers. Hohlblaskörper aus Kunststoff. F.R. Rimkus & W. Stolze. 2010. Paperback, 112 pp. ISBN 978 3 87193 405 6 $143.00

►Vol. 24: Foils. Folien. T. Doege. 2001. Paperback, 84 pp. ISBN 3 87193 225 6 $99.00

NEW! ► Vol. 26 Medical Needles. 2009. describes the basic principles and features for defect evaluation for medical needles with plastic and/or metal hub, perfusion instruments, indwelling needles and needles connected to other medical devices or packaging materials. ISBN 9783871933783. $109.00

►Vol. 34: Applicators and Measuring Devices Made of Plastic. Applikatoren und Meßeinrichtungen aus Kunststoff. P. Raimann & H.D. Ruthemann. 1989. Paperback, 40 pp. ISBN 3 87193 105 5 $36.00

►Vol. 35: Disposable Syringes and Needles. Eimmalspritzen und Kanülen. F.R. Rimkus & P. Raimann. 1990. Paperback, 56 pp. ISBN 3 87193 109 8 $56.00

►Vol. 36: Packaging Materials Made of Corrugated Board. Packmittel aus Wellpappe. F.R. Rimkus, P. Raimann & W. Stolze. 2008, 3rd ed. with CDROM. Paperback, 80 pp. ISBN 978 3 87193 373 8 $115.00

►Vol. 37: Bags and Liners Made of Plastic and Plastic-containing Materials. Beutel und Säcke aus Kunststoff und Kunststoffverbunden. F.R. Rimkus & P. Raimann. 1995. Paperback, 76 pp. ISBN 3 87193 164 0 $67.00

►Vol. 38. Defect Evaluation List for Tins and Lids Made of Metal. author: Fritz Reinhard Rimkus, Jochen Bartels. language: German, English. edition / year of publication: 1st. edition, 2006. Series: Quality Assurance of Pharmaceutical and Cosmetic Packaging Materials (Defect and evaluation lists), Volume 38. Useful working instructions for the testing of pharmaceutical packages (complying with GMP regulations) - Tins and Lids Made of Metal. Taking into consideration pharmaceutical and cosmetic aspects and complying with available recommendations of the German Quality Assurance Society, Military Standards 105 D and 414, the VG Sheets of Bundesbeschaffungsamt (BWB) and Guideline DIN 40 080, several packaging control experts from various pharmaceutical and cosmetics companies have compiled an extensive and detailed documentation on the quality assurance of packaging materials. They can be considered an essential aid for the manufacturing and processing industries. 72 pages incl. CD-ROM. paperback. ISBN 10: 3-87193-344-9; ISBN 13: 978-3-87193-344-8. $99.00

►Vol. 39: Tubes Made of Aluminium. Tuben aus Aluminium. R. Besch & W. Stolze. 2007. Paperback, 76 pp. and CDROM. ISBN 13: 978-3-87193-367-7. $115.00

►Vol. 40: Defect Evaluation List for Tubes Made of Laminate and Plastic. edition / year of publication: 2001. author: M. Treutner, W. Stolze
language: bilingual (German - English). extent: 72 pages incl. CD-ROM. format, cover: 24 x 17 cm, paperback. ISBN 10: 3-87193-242-6; ISBN 13: 978-3-87193-242-7. $99.00

EC Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. 4th Edition. 2009. . Paperback, 244 pp. ISBN 13: 978-3-87193-395-0. $92.00

European Genetic Engineering Law.
Edited by H. Hasskarl. 2002.
Since the two detailed Council Directives on the "Contained Use" and the "Deliberate Release" in April 1990, the European Genetic Engineering law has been amended again and again. Problems of genetic engineering, including all legal regulations, have become of increasing interest to the public. At present there is discussion of an amendment of the Novel Food Directive, which will add a decisive completion to the information of the customer. These recent developments caused the editor and the publishing house to compile all relevant EC Regulations and EC Directives in a book. This edition contains the respective texts in both German and English.
ISBN 3 87193 267 1 $51.00

Pharmaceutical Dictionary: German - English - French - Espanõl. 5th Edition. 2010. This practice-orientated dictionary, now includes Spanish terms, with more than 6000 entries. This specialized dictionary is a practical help for the pharmaceutical industry and their suppliers, public administration, academia, translation agencies and many more. Entries concern the production, quality control and assurance, marketing authorization etc. Print version: 978-3-87193-386-8 $151.00

NEW►The Pharmaceutical Technician. 6th edition.
Basic Knowledge & GMP Training for Employees in Pharmaceutical Companies.
Th. Barthel, U Fritzsche & P. Schwarz. 2003.
The 6th edition of this well established and proven textbook for day-to-day practice in the pharmaceutical industry is now available in English again. Thus it may be used for training purposes beyond the German language barriers. It is intended mainly for the staff - regardless of their educational background - in pharmaceutical companies and laboratories. The book imparts the necessary basic knowledge including pertinent information on Good Manufacturing Practice (GMP). Numerous photos, graphs and tables illustrate and complement the textual contents. Questions at the end of a particular section facilitate the acquirement of the subject matter. The major terminology is explained in a glossary, and an index is also provided. Paperback, 200 pp.
ISBN 3 87193 282 5 $97.00

NEW►Starting a Business in the Life Sciences.
From Idea to Market.
Edited by Henrik Luessen. 2003.
Biotechnology/Life Science caused a real boom at both the stock exchange and in the industry. Notwithstanding its decline, new business ideas are still created and realized in this sector. This practice-oriented guide provides comprehensive background knowledge for promoters of firms and all others involved in the sphere of biotechnology. A wide range of subjects from business plan, financing, question of location, patent portfolios, and cooperations to long-term perspectives of prevailing on hte market are dealt with. The four chapters are divided into these categories: I Establishing the Company • II From Ideas and Intellectual Properties to an Established Business Relationship • III Maturing the Company • IV Personal Experiences of Selected Successful Company Starters. Bilingual German/English edition. Target audience: Promoters of firms, university schools of biochemistry, pharmacy, chemistry, biology, microbiology, biotechnology, medicines, conulsting firms and compnaies supporting life-science companies, bio-science parks, banks, venture capital providers, companies from USA or Asia intending to establish European branches. Paperback, 328 pp.
ISBN 3 87193 277 9 $187.00

UV and IR Spectra of Some Important Drugs.
H.W. Dibbern, R.M Muller, & E. Wirbitzki. 2002.
This English language collection contains the PDF files for 1,552 UV and IR spectra of important pharmaceutical agents and 121 IR spectra of pharmaceutical and cosmetic excipients. The CD-ROM offers one electronic "page" for each substance. The pages presenting the agents contain, besides the spectra, the structural formula, a table with characteristic UV absorption data and some information on the therapeutic use. For excipients, a list which is arranged alphabetically and by substance name is available to the user; in addition, the user can select a page via an index of therapeutic uses or a specfinder list. The substance pages can be selected via an alphabetical list like with the excipients. This collection of spectra is available in English. User information may be retrieved bilingually (English and German). CD-ROM.
ISBN 3 87193 238 8 $646.00

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