chapter 1 Current Challenges and Future Directions of Drug Development / chapter 2 Preclinical Drug Discovery and Development / chapter 3 The IND Process for New Drug Products / chapter 4 Performance and Interpretation of Laboratory Tests / chapter 5 Issues in Endpoint Selection / chapter 6 Dix, Cent, Mille: Proof of Principle with chapter 7 Clinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric Populations -- chapter 8 Electronic Capture of Clinical Trial Information / chapter 9 Providing Patient Access to Promising Investigational Drugs / chapter 10 Issues in the Review of Clinical Drug Trials by IRBs / chapter 11 Personal Care and Randomized Clinical Trials: Understanding the Ethical Conflicts -- chapter 12 Informed Consent in Clinical Trials: Emerging Issues / chapter 13 Orphan Drug Development: David and Goliath / chapter 14 Single-Event Adverse Drug Reactions: Tribulations in Ascribing Causality / chapter 15 How to Deal with a Sudden, Unexpected Death in Clinical Studies / chapter 16 Clinical Trial Material—The Fuel for Clinical Research / chapter 17 The Role of Pharmacokinetics in Drug Development / chapter 18 Building an NDA/BLA / chapter 19 International Planning of Drug Clinical Trials / chapter 20 Uncertainty in Drug Development: Approval Success Rates for New Drugs / chapter 21 Contract Clinical Research: Value to In-House Drug Development / chapter 22 Package Inserts as Viewed by the Busy Private Practitioner / chapter 23 New Directions in Pharmaceutical Promotion: Regulatory Concerns and Contrivances -- chapter 24 The Campus Researcher and Industry: Issues of Intellectual Property and Technology Transfer -- chapter 25 Anatomy of Drug Withdrawals in the United States