chapter 1 Introduction to Generic Drug Product Development / chapter 2 Active Pharmaceutical Ingredients / chapter 3 Analytical Methods Development andMethodsValidation for Solid Oral Dosage Forms / chapter 4 Experimental Formulation Development / chapter 5 Scale-Up, ProcessValidation, and TechnologyTransfer / chapter 6 Drug Stability / chapter 7 Quality Control and QualityAssurance / chapter 8 Drug Product Performance, InVitro / chapter 9 ANDARegulatoryApproval Process / chapter 10 Bioequivalence and Drug Product Assessment, InVivo / chapter 11 Statistical Considerations for Establishing Bioequivalence / chapter 12 Scale-up, Post-approval Changes, and Post-marketing Surveillance / chapter 13 Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations / chapter 14 Legal and Legislative Hurdles to Generic Drug Development, Approval, andMarketing