1.2 An Overview of the Drug Discovery and Development Process 2 -- 1.3 The Pharmaceutical Industry 5 -- 1.4 Economics of Drug Discovery and Development 10 -- 1.5 Trends in Drug Discovery and Development 11 -- Chapter 2 Drug Discovery: Targets and Receptors 15 -- 2.1 Drug Discovery Processes 16 -- 2.2 Medical Needs 16 -- 2.3 Target Identification 18 -- 2.4 Target Validation 25 -- 2.5 Drug Interactions with Targets or Receptors 26 -- 2.6 Enzymes 30 -- 2.7 Receptors and Signal Transduction 32 -- 2.8 Assay Development 39 -- Chapter 3 Drug Discovery: Small Molecule Drugs 43 -- 3.2 Irrational Approach 44 -- 3.3 Rational Approach 50 -- 3.4 Antisense Approach 67 -- 3.5 Chiral Drugs 68 -- Chapter 4 Drug Discovery: Large Molecule Drugs 75 -- 4.2 Vaccines 77 -- 4.3 Antibodies 85 -- 4.4 Cytokines 92 -- 4.5 Hormones 97 -- 4.6 Gene Therapy 99 -- 4.7 Stem Cells 102 -- Chapter 5 Drug Development and Preclinical Studies 107 -- 5.2 Pharmacodynamics 110 -- 5.3 Pharmacokinetics 115 -- 5.4 Toxicology 127 -- 5.5 Animal Tests, In Vitro Assays and In Silico Methods 130 -- 5.6 Formulations and Delivery Systems 132 -- Chapter 6 Clinical Trial 139 -- 6.1 Definition of Clinical Trial 140 -- 6.2 Ethical Considerations 140 -- 6.3 Clinical Trials 144 -- 6.4 Regulatory Requirements for Clinical Trials 147 -- 6.5 Role of Regulatory Authorities 155 -- 6.6 Gene Therapy Clinical Trial 156 -- Chapter 7 Regulatory Authorities 159 -- 7.1 Role of Regulatory Authorities 160 -- 7.2 US Food and Drug Administration 161 -- 7.3 European Agency for the Evaluation of Medicinal Products 166 -- 7.4 Japan's Ministry of Health, Labour and Welfare 167 -- 7.5 China's State Drug Administration 168 -- 7.6 Other Regulatory Authorities 169 -- 7.7 Authorities other than Drug Regulatory Agencies 170 -- 7.8 International Conference on Harmonization 171 -- 7.9 World Health Organization 171 -- 7.10 Pharmaceutical Inspection Cooperation Scheme 172 -- Chapter 8 Regulatory Applications 175 -- 8.2 Food and Drug Administration 176 -- 8.3 European Union 193 -- 8.4 Japan 206 -- 8.5 China 207 -- Chapter 9 Good Manufacturing Practice: Regulatory Requirements 211 -- 9.2 United States 212 -- 9.3 Europe 218 -- 9.4 International Conference on Harmonization 218 -- 9.5 Core Elements of GMP 222 -- 9.6 Selected GMP Systems 232 -- 9.7 The FDA's New cGMP Initiative 243 -- Chapter 10 Good Manufacturing Practice: Drug Manufacturing 247 -- 10.2 GMP Manufacturing 250 -- 10.3 GMP Inspection 252 -- 10.4 Manufacture of Small Molecule APIs 259 -- 10.5 Manufacture of Large Molecule APIs 267 -- 10.6 Finished Dosage Forms 274 -- Chapter 11 Future Perspectives 281 -- 11.1 Past Advances and Future Challenges 281 -- 11.2 Small Molecule Pharmaceutical Drugs 282 -- 11.3 Large Molecule Biopharmaceutical Drugs 285 -- 11.4 Traditional Medicine 285 -- 11.5 Individualized Medicine 287 -- 11.6 Gene Therapy 288 -- 11.7 Cloning and Stem Cells 289 -- 11.8 Old Age Diseases and Aging 291 -- 11.9 Lifestyle Drugs 293 -- 11.10 Performance-Enhancing Drugs 294 -- 11.11 Chemical and Biological Terrorism 295 -- 11.12 Transgenic Animal and Plants 297 -- 11.13 Regulatory Issues 298 -- 11.14 Intellectual Property Rights 299 -- Appendix 1 History of Drug Discovery and Development 305 -- A1.1 Early History of Medicine 305 -- A1.2 Drug Discovery and Development in the Middle Ages 308 -- A1.3 Foundation of Current Drug Discovery and Development 308 -- A1.4 Beginnings of Modern Pharmaceutical Industry 309 -- A1.5 Evolution of Drug Products 310 -- Appendix 2 Cells, Nucleic Acids, Genes and Proteins 313.

Statistics show that out of five thousand compounds with initial promise, five will go into human clinical trials, and only one will become an approved drug. This tiny fraction illustrates the huge complexities involved in bringing a drug to market, a process that brings together scientific research, medical ethics, business, and various regulatory agencies. \Drugs: From Discovery to Approval\ presents a clear, step-by-step overview of the entire process. Using simple language, this comprehensive guide introduces basic concepts, then moves on to discuss disease target selection and the discovery processes for both small and large molecule drugs. Subsequent chapters explain preclinical studies, clinical trials, regulatory issues, good manufacturing practices (GMPs), and perspectives on the future. The coverage also includes: a helpful listing of current FDA and European guidelines; a special section on regulatory authorities and processes in Japan and China; rich illustrations throughout, including more than ninety figures and tables; useful appendices on the history of drug discovery and development; and, representative examples of drug mechanisms in action. Written for professionals in the pharmaceutical industry, and readily accessible for students of pharmacy or medicine and others interested in drug discovery, \Drugs: From Discovery to Approval\ represents a practical and approachable reference on this important process.