New drug development : regulatory paradigms for clinical pharmacology and biopharmaceutics / edited by Chandrahas G. Sahajwalla.

CONTENT

PART I HISTORY AND BASIC PRINCIPLES
Chapter 1. Introduction to Drug Development and Regulatory Decision-Making
Chapter 2. Evolution of Drug Development and its Regulatory Process
Chapter 3. Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application
Chapter 4. New Drug Application Content and Review Process for Clinical Pharmacology and Biopharmaceutics

PART II IN VITRO / PRE-CLINICAL
Chapter 5. In-vitro Drug Metabolism Studies During Development of New Drugs
Chapter 6. Drug Transporters
Chapter 7. Principles, Issues, and Applications of Interspecies Scaling

PART III CLINICAL PHARMACOLOGY
Chapter 8. Analytical Method Validation
Chapter 9. Studies of the Basic Pharmacokinetic Properties of a Drug - a Regulatory Perspective
Chapter 10. Surrogate Markers in Drug Development
Chapter 11. Population Pharmacokinetic and Pharmacodynamic Analysis
Chapter 12. Scientific and Regulatory Considerations for Studies in Special Populations
Chapter 13. Conducting Clinical Pharmacology Studies in Pregnant and Lactating Women
Chapter 14. Scientific, Mechanistic and Regulatory Issues with Pharmacokinetic Drug-Drug Interactions
Chapter 15. Assessing the Effect of Disease State on the Pharmacokinetics of the Drug
Chapter 16. Clinical Pharmacology Issues Related to Specific Drug Classes During Drug Development

PART IV BIOPHARMACEUTCS
Chapter 17. Issues in Bioequivalence and Development of Generic Drug Products
Chapter 18. Regulatory Considerations for Oral Extended Release Dosage Forms and in vitro (Dissolution)/in vivo (Bioavailability) Correlations
Chapter 19. In vivo Bioavailability/Bioequivalence Waivers
Chapter 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
Chapter 21. Scientific and Regulatory Issues in Development of Chiral Drugs
Chapter 22. A Regulatory View of Liposomal Drug Product Characterization
Chapter 23. Challenges in Drug Development: Biological Agents of Intentional Use
Chapter 24. The Regulation of Antidotes for Nerve Agent Poisoning
Chapter 25. Bioequivalence Assessment: Approaches, Designs, and Statistical Considerations

Includes references and index