1st Edition
New Drug Development Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics
Edited By Chandrahas Sahajwalla
Copyright 2004
602 Pages
by
CRC Press
500 Pages
by
CRC Press
Also available as eBook on:
Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.
Preface Part I History and Basic Principles 1. Introduction to Drug Development and Regulatory Decision-Making 2. Evolution of Drug Development and its Regulatory Process 3. Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application 4. New Drug Application Content and Review Process for Clinical Pharmacology and Biopharmaceutics Part II In Vitro/Pre-Clinical In-vitro Drug Metabolism Studies During Development of New Drugs 6. Drug Transporters 7. Principles, Issues, and Applications of Interspecies Scaling Part III Clinical Pharmacology 8. Analytical Method Validation 9. Studies of the Basic Pharmacokinetic Properties of a Drug: A Regulatory Perspective Perspective 10. Surrogate Markers in Drug Development 11. Population Pharmacokinetic and Pharmacodynamic Analysis 12. Scientific and Regulatory Considerations for Studies in Special Population 13. Conducting Clinical Pharmacology Studies in Pregnant and Lactating Women 14. Scientific, Mechanistic, and Regulatory Issues with Pharmacokinetic Drug-Drug Interactions 15. Assessing the Effect of Disease State on the Pharmacokinetics of the Drug 16. Clinical Pharmacology Issues Related to Specific Drug Classes During Drug Development Part IV Biopharmaceutics 17. Issues in Bioequivalence and Development of Generic Drug Products 18. Regulatory Considerations for Oral Extended Release Dosage Forms and in vitro (Dissolution)/in vivo (Bioavailability) Correlations 19. In vivo Bioavailability/Bioequivalence Waivers 20. Bioavailability and Bioequivalence Issues for Drugs Administered via Different Routes of Administration; Inhalation/Nasal Products; Dermatological Products, Suppositories Part V Contemporary and Special Interest Topics 21. Scientific and Regulatory Issues in Development of Chiral Drugs 22. A Regulatory View of Liposomal Drug Product Characterization 23. Challenges in Drug Development: Biological Agents of Intentional Use 24. The Regulation of Antidotes for Nerve Agent Poisoning 25. Bioequivalence Assessment: Approaches, Designs, and Statistical Considerations
Biography
Chandrahas Sahajwalla
"…the chapters are readable, the figures are clear in reproduction, the result being a useful text that I believe meets its goal of being an introductory text to drug development from a pharmacokinetic regulatory point-of-view."
-Pharmaceutical Research
"…a timely book which combines the scientific and regulatory aspects of clinical pharmacology and biopharmaceutics in easy-to-understand chapters that cover all aspects of drug development….fills an existing void and further provides a quick reference guide for the industrial or academic scientist who is new in the field."-
. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, and Acting Deputy Commissioner for Operations, Food and Drug Administration
