part PART I Preparation for Clinical Trials -- chapter 1 Drug Discovery and Preclinical Research -- chapter 2 The Pharmacuetical Background -- chapter 3 The Pharmacological Background for Drug Evaluation -- chapter 4 Animal Tests as Predictors of Human Response -- part PART II Regulatory Organization and Decision Making -- chapter 5 Worldwide Regulatory Agencies -- chapter 6 Decision Point in Drug Development -- chapter 7 Management of Clinical Development Costs -- chapter 8 Ethical Aspects and Good Clinical Practice -- chapter 9 Investigational New Drug Appliation and the Licensure Approval Process -- chapter 10 Clinical Trials from Phase I to Phase IV -- part PART III Evaluation and Quality Assurance of Drugs and Biopharmaceuticals -- chapter 11 The Assessment of Pharmacokinetics in Early-Phase Drug Evaluation -- chapter 12 Drug Interactions -- part PART IV Assessment of Cardiovascular Drugs -- chapter 13 Antianginal Drugs -- chapter 14 Antihypertensive Drugs -- chapter 15 Drugs for Treatment of Stroke -- part PART V Assessment of Respiratory Drugs -- chapter 16 Antiasthmatic Drugs -- part PART VI Assessment of Central Nervous System Drugs -- chapter 17 Anxiolytics and Hypnotics -- chapter 18 Antidepressants -- chapter 19 Drugs for Alzheimer's Disease and Other Dementias -- part PART VII Assessment of Gastrointestinal and Liver Drugs -- chapter 20 Antiulcer Drugs -- part PART VIII Assessment of Genitourinary Drugs -- chapter 21 Diuretics -- chapter 22 Medical Therapy of Benign Prostatic Hyperplasia -- part PART IX Assessment of Skin Drugs -- chapter 23 Drugs for the Treatment of Specific Skin Diseases -- chapter 24 Drugs for the Treatment of Atopic Eczema -- part PART X Assessment of Metabolism Drugs -- chapter 25 Drugs for Treatment of Disorder of Lipid Metabolism -- chapter 26 Antidiabetic Drugs -- part PART XI Assessment of Chemotherapeutic Drugs -- chapter 27 Antibiotics / chapter 28 Antiviral Drugs / chapter 29 Anticancer Drugs / part PART XII Assessment of Antiinflammatory and Pain Drugs -- chapter 30 Analgesics / part PART XIII Assessment of Biopharmaceuticals -- chapter 31 Vaccines / chapter 32 Herbal Products as Complementary and Alternative Medicine / chapter 33 CHAPTER. Biotechnology-Derived Pharmaceuticals / part PART XIV Future Perspective -- chapter 34 Future Perspectives in Drug Development / chapter 35 Future Perspectives in Biopharmaceutical Development