Drugs: From Discovery to Approval / Edition 2

Drugs: From Discovery to Approval / Edition 2

by Rick Ng
ISBN-10:
047019510X
ISBN-13:
9780470195109
Pub. Date:
11/24/2008
Publisher:
Wiley
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Overview

Drugs: From Discovery to Approval / Edition 2

Praise for the First Edition

"A concise, yet comprehensive, survey of the entire drug development process."
Journal of Chemical Technology and Biotechnology

The new edition of this bestselling 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 preclinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs.

This Second Edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter; Answers to Review Questions provided in an appendix; and carefully selected "mini" case studies in each chapter.

Richly illustrated throughout with over ninety figures and tables, this important new edition also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.

Product Details

ISBN-13: 9780470195109
Publisher: Wiley
Publication date: 11/24/2008
Edition description: Older Edition
Pages: 480
Product dimensions: 6.40(w) x 9.30(h) x 1.00(d)

Table of Contents

Preface xiii

1 Introduction 1

1.1 Aim of This Book 1

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 12

1.6 Case Study #1 14

1.7 Summary of Important Points 16

1.8 Review Questions 16

1.9 Brief Answers and Explanations 16

1.10 Further Reading 17

2 Drug Discovery: Targets and Receptors 19

2.1 Drug Discovery Processes 20

2.2 Medical Needs 21

2.3 Target Identification 23

2.4 Target Validation 28

2.5 Drug Interactions with Targets or Receptors 30

2.6 Enzymes 34

2.7 Receptors and Signal Transduction 38

2.8 Assay Development 45

2.9 Case Study #2 46

2.10 Summary of Important Points 50

2.11 Review Questions 50

2.12 Brief Answers and Explanations 51

2.13 Further Reading 51

3 Drug Discovery: Small Molecule Drugs 53

3.1 Introduction 54

3.2 Irrational Approach 55

3.3 Rational Approach 60

3.4 Antisense Approach 79

3.5 RNA Interference Approach 81

3.6 Chiral Drugs 83

3.7 Closing Remarks 84

3.8 Case Study #3 84

3.9 Summary of Important Points 88

3.10 Review Questions 89

3.11 Brief Answers and Explanations 90

3.12 Further Reading 91

4 Drug Discovery: Large Molecule Drugs 93

4.1 Introduction 94

4.2 Vaccines 95

4.3 Antibodies 106

4.4 Cytokines 113

4.5 Hormones 121

4.6 Gene Therapy 124

4.7 Stem Cells and Cell Therapy 126

4.8 Case Study #4 128

4.9 Summary of Important Points 131

4.10 Review Questions 132

4.11 Brief Answers and Explanations 133

4.12 Further Reading 134

5 Drug Development and Preclinical Studies 136

5.1 Introduction 137

5.2Pharmacodynamics 139

5.3 Pharmacokinetics 143

5.4 Toxicology 155

5.5 Animal Tests, In Vitro Assays, and In Silico Methods 158

5.6 Formulations and Delivery Systems 161

5.7 Nanotechnology 168

5.8 Case Study #5 169

5.9 Summary of Important Points 171

5.10 Review Questions 172

5.11 Brief Answers and Explanations 173

5.12 Further Reading 174

6 Clinical Trials 176

6.1 Definition of Clinical Trial 177

6.2 Ethical Considerations 177

6.3 Clinical Trials 181

6.4 Regulatory Requirements for Clinical Trials 186

6.5 Role of Regulatory Authorities 199

6.6 Gene Therapy Clinical Trial 199

6.7 Case Study #6 200

6.8 Summary of Important Points 204

6.9 Review Questions 205

6.10 Brief Answers and Explanations 205

6.11 Further Reading 206

7 Regulatory Authorities 208

7.1 Role of Regulatory Authorities 209

7.2 US Food and Drug Administration 210

7.3 European Medicines Agency 214

7.4 Japan's Ministry of Health, Labor and Welfare 216

7.5 China's State Food and Drug Administration 217

7.6 India's Central Drugs Standard Control Organization 219

7.7 Australia's Therapeutics Goods Administration 219

7.8 Canada's Health Canada 220

7.9 Other Regulatory Authorities 220

7.10 Authorities Other than Drug Regulatory Agencies 221

7.11 International Conference on Harmonization 222

7.12 World Health Organization 222

7.13 Pharmaceutical Inspection Cooperation Scheme 223

7.14 Case Study #7 225

7.15 Summary of Important Points 227

7.16 Review Questions 228

7.17 Brief Answers and Explanations 228

7.18 Further Reading 229

8 Regulatory Applications 231

8.1 Introduction 232

8.2 Food and Drug Administration 233

8.3 European Union 250

8.4 Japan 263

8.5 China 264

8.6 India 266

8.7 Australia 269

8.8 Canada 269

8.9 Case Study #8 269

8.10 Summary of Important Points 273

8.11 Review Questions 274

8.12 Brief Answers and Explanations 274

8.13 Further Reading 275

9 Good Manufacturing Practice: Regulatory Requirement 278

9.1 Introduction 279

9.2 United States 279

9.3 Europe 283

9.4 International Conference on Harmonization 283

9.5 Core Elements of GMP 287

9.6 Selected GMP Systems 297

9.7 The FDA's New cGMP Initiative 310

9.8 Case Study #9 313

9.9 Summary of Important Points 315

9.10 Review Questions 316

9.11 Brief Answers and Explanations 316

9.12 Further Reading 317

10 Good Manufacturing Practice: Drug Manufacturing 319

10.1 Introduction 320

10.2 GMP Manufacturing 322

10.3 GMP Inspection 325

10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods) 332

10.5 Manufacture of Large Molecule APIs (Recombirant DNA Methods) 340

10.6 Finished Dosage Forms 348

10.7 Case Study #10 352

10.8 Summary of Important Points 355

10.9 Review Questions 356

10.10 Brief Answers and Explanations 356

10.11 Further Reading 357

11 Future Perspectives 359

11.1 Past Advances and Future Challenges 360

11.2 Small Molecule Pharmaceutical Drugs 360

11.3 Large Molecule Biopharmaceutical Drugs 362

11.4 Traditional Medicine 364

11.5 Individualized Medicine 366

11.6 Gene Therapy 366

11.7 Cloning and Stem Cells 367

11.8 Old Age Diseases and Aging 369

11.9 Lifestyle Drugs 371

11.10 Performance-Enhancing Drugs 373

11.11 Chemical and Biological Terrorism 376

11.12 Transgenic Animals and Plants 376

11.13 Antimicrobial Drug Resistance 379

11.14 Regulatory Issues 380

11.15 Intellectual Property Rights 381

11.16 Bioethics 382

11.17 Concluding Remarks 384

11.18 Case Study #11 387

11.19 Further Reading 389

Appendix 1 History of Drug Discovery and Development 391

A1.1 Early History of Medicine 391

A1.2 Drug Discovery and Development in the Middle Ages 394

A1.3 Foundation of Current Drug Discovery and Development 394

A1.4 Beginnings of Modern Pharmaceutical Industry 395

A1.5 Evolution of Drug Products 396

A1.6 Further Reading 397

Appendix 2 Cells, Nucleic Acids, Genes, and Proteins 398

A2.1 Cells 398

A2.2 Nucleic Acids 400

A2.3 Genes and Proteins 404

A2.4 Further Reading 410

Appendix 3 Selected Drugs and Their Mechanisms of Action 411

Appendix 4 A DHFR Plasmid Vector 414

Appendix 5 Vaccine Production Methods 416

Appendix 6 Pharmacology/Toxicology Review Format 418

Appendix 7 Examples of General Biomarkers 424

Appendix 8 Toxicity Grading 428

Appendix 9 Health Systems in Selected Countries 434

Acronyms 436

Glossary 441

Index 445

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