New Drug Development

Chandrahas Sahajwalla

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