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 -- 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 / 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 -- 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 -- 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.