International Pharmaceutical Product Registration, Second Edition

by Matthews; Brian R.

• ISBN13: 9781420081763
• ISBN10: 1420081764
• Edition: 2nd
• Format: Hardcover
• Copyright: 2009-08-26
• Publisher: CRC Press

Summary

With 45 chapters that cover all of the major technical and clinical topics in a Common Technical Document registration, including summaries, quality of the drug substance and dosage form, nonclinical studies and clinical trials, this Second Edition provides a roadmap for International Conference on Harmonisation (ICH) and other technical and regulatory requirements for global filings in the US, EU, Japan and elsewhere.

Author Biography

Anthony C. Cartwright is a Pharmaceutical Regulatory Consultant, Harpenden, UK. Tony Cartwright is involved in numerous professional organizations including the Royal Pharmaceutical Society of Great Britain, the Drug Information Association and The Organisation for Professionals in Regulatory Affairs, where he chairs their Lifelong Learning Committee. He was formerly Chair of the European CPMP Quality Working Party. He was an active participant in working groups and conferences of the International Conference on Harmonisation, particularly involved in guidelines on stability testing and impurities. He has authored over 30 scientific and technical publications and book chapters. He is the Co-editor of Informa Healthcare's Pharmaceutical Product Licensing: Requirements for Europe and the first edition of International Pharmaceutical Product Registration. Brian R. Matthews, Ph D, is Senior Director, EU Registration and Authorised Representative for Alcon Laboratories and is based in the UK. He is involved with a number of professionals associations such as the Parenteral Drug Association, The Organisation for Professional in Regulatory Affairs and the Royal Pharmaceutical Society of Great Britain. He is also involved in a number of standards committee within the British Standards Institution, the European Standards Committee and the International Standards Organization where his particular interests include methods of sterilization, animal materials used in the manufacture of medical devices, contact lens care products, interaocular lenses, irrigation solutions, viscosurgical products and Braille for application to pharmaceutical labelling. He is also a member of committees within the British Pharmacopoeia relating to pharmacy and to microbiology. Brian has written a number of papers on a wide range of topics relating to pharmaceutical legislation. He is on the editorial boards for the Regulatory Affairs Journal (Pharma) and (Medical Devices) and the European Journal of Parenteral and Pharmaceutical Sciences. In addition to co-editing Pharmaceutical Product Licensing: Requirements for Europe and the first edition of International Pharmaceutical Product Registration he is also the author of Pharmaceutical Excipients: A Manufacturer's Handbook.

Table of Contents

Preface	p. vii
Acknowledgments	p. xi
Contributors	p. xv
Introduction and Specific Requirements
The Common Technical Document-A Global Format for Registration Files	p. 1
The Electronic Common Technical Document	p. 14
CTD Module 1-Administrative Information	p. 26
Environmental Risk Assessment	p. 47
Common Technical Document Summaries
Quality Overall Summary	p. 78
The Nonclinical Overview and Summary	p. 89
The Clinical Overview and Summary	p. 107
Quality-Drug Substance and Drug Product
Drug Substance-General Information	p. 119
Drug Substance-Manufacture	p. 124
Drug Substance-Characterization	p. 136
Control of Drug Substance	p. 154
Drug Substance and Drug Product-Container/Closure	p. 169
Drug Product-Description and Composition	p. 179
Drug Product-Pharmaceutical Development	p. 184
Drug Product-Manufacture and Process Validation	p. 210
Drug Product-Excipients	p. 234
Control Tests on the Finished Product	p. 248
Reference Standards or Materials	p. 264
Drug Substance and Drug Product Stability	p. 269
Transmissible Spongiform Encephalopathy Agent and Adventitious Agent Requirements for Non-Biological Pharmaceutical Products	p. 290
Nonclinical Studies
Nonclinical Testing Strategy	p. 300
Pharmacology	p. 323
Nonclinical Pharmacokinetics and Toxicokinetics	p. 336
Single and Repeat Dose Toxicity	p. 377
Genotoxicity	p. 402
Carcinogenicity	p. 419
Reproductive and Developmental Toxicity	p. 429
Safety Pharmacology Testing: Past, Present, and Future	p. 441
Immunotoxicology	p. 467
Local Tolerance and Other Toxicity Studies	p. 478
Clinical Studies
Bioavailability and Bioequivalence Studies	p. 490
Pharmacokinetics in Man	p. 520
Pharmacodynamics	p. 537
Statistical Concepts in the Design and Analysis of Clinical Trials	p. 554
Efficacy and Safety Clinical Studies	p. 574
Postmarketing Evaluation	p. 589
Pharmacovigilance and Risk Management	p. 603
Pregnancy and Children	p. 622
Ageing Populations and Development of Medicinal Products	p. 633
Good Clinical Practice	p. 658
Prevention and Detection of Fraud in Clinical Trials	p. 685
Special Products and Modeling
Aspects of Biological and Biotechnological Medicinal Products	p. 697
Device-Drug Combination Products	p. 717
Recommendations for Toxicological Evaluation of Nanoparticle Medicinal Products Jean-Roger Claude and Members of Afssaps Working Party	p. 755
Modeling and Medical Product R&D	p. 762
List of Acronyms and Abbreviations	p. 774
List of Key Technical and Regulatory Information Sources	p. 784
Index	p. 787
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