Development and evaluation of drugs : from laboratory through licensure to market

목차 (Table of Contents)

• CONTENTS
• CHAPTER 1 INTRODUCTION = 1
• Ⅰ. The Discovery and Development of Drugs = 1
• Ⅱ. The Search for Health - A Dream of Conquering Disease = 5
• A. Gods of Health and Healing = 6
• B. The Magic Bullets of Drugs = 10
• Ⅲ. Drug Development in the Biotechnology Era = 13
• References = 18
• CHAPTER 2 EVALUATION OF DRUGS AND BIOLOGIC PRODUCTS BY REGULATORY AGENCIES = 21
• Ⅰ. The Drug Approval Process and Vaccine Licensure = 26
• A. Pre-Clinical Research and Development = 26
• B. Drug Testing in People - Clinical Trials = 65
• C. New Drug Application (NDA) Review = 70
• D. Post-Marketing Monitoring and Reporting System = 77
• E. The Drug Approval Process in Japan = 82
• Ⅱ. Assurance of Quality - Regulation and Testing of Drugs = 89
• A. FDA's Basic Concept of Regulation = 89
• B. Regulatory Specifications and Methods for Testing = 91
• C. Regulatory Actions = 96
• Figures = 99
• References = 104
• CHAPTER 3 PRACTICAL ASPECTS OF DRUG EVALUATION AND RESPONSE = 111
• Ⅰ. Generic Drugs and Bioequivalence = 111
• Ⅱ. Pharmacokinetic Models for Drug Absorption = 113
• A. Absorption and Bioavailability = 114
• B. Pharmacokinetic Models and their Clinical Application = 119
• Ⅲ. Factors Affecting Response to Drugs = 123
• A. Factors Related to Diet and Environmental Chemicals = 124
• B. Genetic Determinants = 126
• C. Disease Status and Age = 128
• Ⅳ. Mechanisms of Drug Interactions = 131
• A. Receptor Sites of Drug Action = 131
• B. Structure-Activity Relationship of Drugs = 137
• Ⅴ. Adverse Drug Reactions = 138
• A. Causal Relationships between Drugs and Adverse Reactions = 139
• B. Adverse Reactions during Pregnancy and Lactation = 143
• References = 146
• CHAPTER 4 DEVELOPMENT OF NEW DRUGS BY RESEARCH INSTITUTES AND THE PHARMACEUTICAL INDUSTRY = 153
• Ⅰ. The Restless Tide of Research and Development = 153
• Ⅱ. Difficult but Exciting Preclinical Drug Discovery and Tests = 161
• Ⅲ. Strategies and Planning for Clinical Trials = 167
• A. Phase Ⅰ Trial - Safety and Clinical Pharmacology = 168
• B. Phase Ⅱ Trial - Clinical Efficacy and Safety = 168
• C. Phase Ⅲ Trial - Large-Scale Clinical Studies = 169
• Ⅳ. Pharmaceutics and the Drug Delivery System = 171
• References = 178
• CHAPTER 5 CHALLENGING PROBLEMS FOR THE FUTURE = 183
• Ⅰ. The Pursuit of a Healthy and Happy Life in an Aging Society = 184
• Ⅱ. The High Costs of Health Care and Drug Development = 185
• Ⅲ. Liability and Compensation for Drug-Related Damages = 189
• Ⅳ. The Nest Revolution in Modern medicine = 190
• References = 194
• TABLES = 197
• INDEX = 215