Drugs

The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products.
Concise and easy to read, Drugs: From Discovery to Approval, Third Edition quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R&D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for those in this rapidly growing field.

Auteur

Rick Ng, PhD, MBA, has worked for more than 25 years in senior management positions in the private sector pharmaceutical industry. He is currently providing consulting services to the pharmaceutical industry and training for graduates, postgraduates, and pharmaceutical professionals at the National University of Singapore and the University of New South Wales, Australia.

Contenu
Preface xv

1 Introduction 1

1.1 Aim of this Book 1

1.2 An Overview of the Drug Discovery to Approval Process 2

1.3 The Pharmaceutical Industry 6

1.4 Economics of Drug Discovery and Development 11

1.5 Trends in Drug Discovery and Development 13

1.6 Case Study #1.1 15

1.7 Case Study #1.2 17

1.8 Summary of Important Points 20

1.9 Review Questions 20

1.10 Brief Answers and Explanations 21

1.11 Further Reading 22

2 Drug Discovery: Targets and Receptors 23

2.1 Drug Discovery Processes 23

2.2 Medical Needs 24

2.3 Target Identification 26content

2.4 Target Validation 33

2.5 Drug Interactions with Targets or Receptors 36

2.6 Enzymes 40

2.7 Receptors and Signal Transduction 42

2.8 Assay Development 52

2.9 Case Study #2.1 52

2.10 Case Study #2.2 53

2.11 Summary of Important Points 57

2.12 Review Questions 57

2.13 Brief Answers and Explanations 58

2.14 Further Reading 58

3 Drug Discovery: Small Molecule Drugs 61

3.1 Introduction 61

3.2 Irrational Approach 62

3.3 Rational Approach 67

3.4 Antisense Approach 85

3.5 RNA Interference Approach 88

3.6 Chiral Drugs 91

3.7 Closing Remarks 92

3.8 Case Study #3.1 94

3.9 Case Study #3.2 96

3.10 Summary of Important Points 98

3.11 Review Questions 99

3.12 Brief Answers and Explanations 99

3.13 Further Reading 100

4 Drug Discovery: Large Molecule Drugs 103

4.1 Introduction 103

4.2 Vaccines 105

4.3 Antibodies 117

4.4 Cytokines 128

4.5 Hormones 134

4.6 Gene Therapy 137

4.7 Stem Cells and Cell Therapy 139

4.8 Case Study #4.1 141

4.9 Case Study #4.2 144

4.10 Summary of Important Points 146

4.11 Review Questions 147

4.12 Brief Answers and Explanations 148

4.13 Further Reading 148

5 Drug Development and Preclinical Studies 151

5.1 Introduction 151

5.2 Pharmacodynamics 154

5.3 Pharmacokinetics 158

5.4 Toxicology 168

5.5 Animal Tests, In Vitro Assays, and In Silico Methods 172

5.6 Formulations and Delivery Systems 175

5.7 Nanotechnology 183

5.8 Case Study #5.1 184

5.9 Case Study #5.2 185

5.10 Summary of Important Points 187

5.11 Review Questions 188

5.12 Brief Answers and Explanations 188

5.13 Further Reading 189

6 Clinical Trials 191

6.1 Definition of Clinical Trial 191

6.2 Ethical Considerations 192

6.3 Clinical Trials 195

6.4 Regulatory Requirements for Clinical Trials 204

6.5 Clinical Data Management 215

6.6 Role of Regulatory Authorities 218

6.7 Gene Therapy Clinical Trial 218

6.8 Adaptive Clinical Trial 220

6.9 Meta-Analysis 221

6.10 Case Study #6.1 222

6.11 Case Study #6.2 226

6.12 Summary of Important Points 227

6.13 Review Questions 228

6.14 Brief Answers and Explanations 228

6.15 Further Reading 229

7 Regulatory Authorities 231

7.1 Role of Regulatory Authorities 231

7.2 US Food and Drug Administration 233

7.3 European Medicines Agency 236

7.4 Japan's Pharmaceuticals and Medical Devices Agency (PMDA) 238

7.5 China Food and Drug Administration 240

7.6 India's Central Drugs Standard Control Organization 240

7.7 Australia's Therapeutic Goods Administration 241

7.8 Canada's Health Canada 243 7.9 Other Regulatory Authorities 243</p&gt...