In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.
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Inside This Book
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First Sentence:
Until recently, the diversity of requirements for stability data and interpretation among the major pharmaceutical markets of the world has made the construction of the "chemisty and pharmacy" section of an international registration application a complicated and, sometimes, daunting task. Read the first page Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, International Conference, European Union, Member States, World Health Organization, Pharmacopeial Forum, Good Manufacturing Practice, New York, Steering Committee, Federal Register, Quality of Biotechnological Products, Drugs Made, European Commission, European Community, European Pharmacopoeia, European Federation of Pharmaceutical, Japanese Pharmacopoeia, Northern Ireland, Available Level, Expert Working Group, Pack Type, Pharmaceutical Solids, Product Information, Therapeutic Goods Administration, United Kingdom New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Until recently, the diversity of requirements for stability data and interpretation among the major pharmaceutical markets of the world has made the construction of the "chemisty and pharmacy" section of an international registration application a complicated and, sometimes, daunting task. Read the first page Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, International Conference, European Union, Member States, World Health Organization, Pharmacopeial Forum, Good Manufacturing Practice, New York, Steering Committee, Federal Register, Quality of Biotechnological Products, Drugs Made, European Commission, European Community, European Pharmacopoeia, European Federation of Pharmaceutical, Japanese Pharmacopoeia, Northern Ireland, Available Level, Expert Working Group, Pack Type, Pharmaceutical Solids, Product Information, Therapeutic Goods Administration, United Kingdom New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 15
books:
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9
books
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- WHO Expert Committee on Specifications for Pharmaceutical Preparations (40th report) (WHO Technical Report Series) by World Health Organization on page 271, page 299, and page 310
- Particle Size Measurement Volume 1 by Terence Allen on page 206, and page 212
- Microbiological Quality Assurance: A Guide Towards Relevance and Reproducibility of Inocula by Michael R.W. Brown on page 190, and page 191
- European Union (Aspects of Britain) by Central Office of Information on page 42, and page 49
- British Pharmacopoeia (2000 ed.) (4 Volume Slipcase Set) by Tso on page 189
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- Audit by Mail: Time and Cost Effective GMP Audit Tool by John Lyall in Back Matter
- The GCP Harmonization Handbook by Donald E. Maynard in Back Matter
- International Clinical Trials: A Guidebook and Compendium of National Drug Laws, Two-Volume Set by Dominique Brunier in Back Matter
- Compliance Auditing for Pharmaceutical Manufacturers: A Practical Guide to In-Depth Systems Auditing by Karen Ginsbury in Back Matter
- Clinical Research Coordinator Handbook: GCP Tools and Techniques, Second Edition (Practical Clinical Trials) by Deborah Rosenbaum in Back Matter
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