See other pharmaceutical books from European Union Publishers on cosmetics, excipients, etc.

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Handbook of Pharmaceutical Excipients.  Book format $375, CDROM format $375, Book/CDROM package $575.00

Herbal Medicines. Third edition. due September 2007. Joanne Barnes - Associate Professor in Herbal Medicines, School of Pharmacy, University of Auckland, New Zealand, Linda A Anderson - Principal Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency, London and J David Phillipson - Emeritus Professor, Centre for Pharmacognosy and Phytotherapy, School of Pharmacy, London.

Herbal Medicines is an invaluable reference text for pharmacists and other healthcare professionals.  
Herbal medicinal products are increasing in popularity in the developed world and continue to be an important healthcare approach in developing countries. However, alongside the widespread use of herbal medicines, there are many concerns about their quality, safety and efficacy. Herbal Medicines provides a comprehensive single source of scientifically rigorous, impartial information on over 150 of the most commonly used herbal medicinal products. This third edition has been extensively revised and updated.  

Features include:  

• Full colour throughout, with chemical structures and photographs of the plant and crude drug material  
• 152 monographs, comprehensively referenced, detailing phytochemical, pharmacological and clinical aspects of each herb (uses, dosage, evidence of efficacy, adverse effects, contraindications, use in pregnancy and lactation, drug interactions, etc.)   
• New monographs on butterbur (Petasites hybridus), greater celandine (Chelidonium majus), kava (Piper methysticum) and rhodiola (Rhodiola rosea)
• Monographs on around 20 major herbal medicines substantially revised, including echinacea, evening primrose, ginkgo, ginseng, St John's wort and valerian   
• Product information from over 30 countries including Australia, Germany, UK and USA.  

  Written by experts in the fields of pharmacognosy, phytochemistry, phytopharmacy, clinical herbal medicines, phytopharmacovigilance and regulation of herbal medicinal products, Herbal Medicines is an invaluable reference text for pharmacists and other healthcare professionals who require evidence-based information on herbal medicines used for treatment and prevention of health problems. Hardback ISBN: 978 0 85369 623 0. 720pp. $150.00; CDROM single user ISBN: 978 0 85369 642 1. $150.00; CDROM & Book ISBN: 978 0 85369 656 8. $200.00

**Unfortunately, since publication, the publisher has become aware of a problem affecting the contents of the ‘Preparations’ section in both the book (978 085369 623 0) and CD-ROM (978 085369 642 1). Some preparations data became corrupted during the production process and some information has been incorrectly transferred from one herbal monograph to an adjacent monograph. In total, 10 monographs and Appendix 4 has been affected. The enclosed corrigenda provides replacement ‘Preparations’ sections for the affected monographs. Pharmaceutical Press would like to apologise for this error. You can download the corrigenda here for your use.

Martindale. The Complete Drug Reference. Thirty-fifth edition. Edited by Sean C Sweetman. 2007.

• 5,500 drug monographs  
• 128,000 preparations  
• 40,700 reference citations  
• 10,900 manufacturers  
• Synopses of disease treatments  
• Enables identification of medicines, the local equivalent and the manufacturer  
• Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines  
• Based on published information and extensively referenced  
• Now in 2 volumes  
• Chapters reorganised to better reflect the clinical use of drugs  
• International Nonproprietary Names now in English, French, Latin, Russian and Spanish   
• Increase in synonyms from Scandinavia, Baltic and Eastern European areas  
• Increased coverage of 'street names' for drugs and substances liable to abuse  
• Indication of drugs restricted or banned by sports authorities  
• Molecular structural formulae included for selected drugs  
• Coverage of proprietary preparations expanded to 36 countries, now including Czech Republic, Hungary, Russia and Venezuela  

ISBN: 978 0 85369 687 2. $550.00 printed, for cdrom single user only ISBN: 978 0 85369 703 9, $550.00: for cdrom/printed combo ISBN: 978 0 85369 704 6. $695.00

Fiedler - Encyclopedia of Excipients. Hoepfner, Eva-Marie; Lang, Siegfried; Reng, Alwin; Schmidt, Peter Christian. due Spring. 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 durgs, dangerous substances, food additives, preservatives, sieves, solubilizers, surfactants, etc.  1600 pp. hardcover. 2 volumes. ISBN: 3-87193-346-5. $560.00; CDROM version: ISBN 3-87193-347-3. $560.00

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. $608.00

MHLW Ministerial Ordinances on GQP and GMP 2005. April 2006. Provides the whole text of these four MHLW Ministerial Ordinances Established/Revised in 2004/2005. including: Standards for Quality Assurance of Drugs, Quasi-drugs, Cosmetics and Medical Devices [GQP Ministerial Ordinance] (MHLW Ministerial Ordinance No. 136 Established as of September 22, 2004); Regulations for Buildings and Facilities for Pharmacies etc. [Buildings and Facilities Regulations] (MHLW Ministerial Ordinance No. 180 Revised as of December 24, 2005); Standards for Manufacturing Control and Quality Control of Drugs and Quasi-drugs [GMP Ministerial Ordinance on Drugs and Quasi-drugs] (MHLW Ministerial Ordinance No. 179 Revised as of December 24, 2004); Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostics [QMS Ministerial Ordinance on Medical Devices and In Vitro Diagnostics] (MHLW Ministerial Ordinance No. 169 Revised as of December 17, 2004) 234 pages, ISBN4-8408-0842-2 C3047, Paperbound, A5 format (148 x 210 mm) in Japanese and English. $110.00

The Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations 2005/07. 2005; pp. 294; A5 format (148 x 210 mm); paperback; ISBN 4-8408-0863-5. Provides the whole text of the Pharmaceutical Affairs Law, Ordinance and Regulations revised in July 2005. US$150 ( pertains to Japan!)

The Japanese GMP Regulations 2003. Ministry of Health, Labour and Welfare. 2003. Covers regulations for buildings and facilities for pharmacies; regulations for manufacturing control and quality control of drugs; regulations for importing/retail management and quality control of drugs and quasi-drugs; MHLW Ministerial Ordinance on the manufacturing control and quality control when manufacturing of a single product of the drugs, quasi-drugs, cosmetics and medical devices specified under article 1-2-2....; good manufacturing practice guide for active pharmaceutical ingredients. 190 pp, paperback. ISBN 4-8408-0761-2. in English & Japanese. $160.00

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