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Drugs

Rick Ng
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The third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes... Weiterlesen
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Beschreibung

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.

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.

Autorentext

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.

Klappentext

THIRD EDITION

DRUGS
From Discovery to Approval

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 and 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; the third edition of the text provides timely updates for those in this rapidly growing field.

  • Revised edition will have greater appeal to students with the inclusion of more materials and case studies suited to college and university use
  • Includes the latest developments and updates
  • Increased appeal by provision of more comprehensive topics


Inhalt

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

7.10 Authorities other than Drug Regulatory Agencies 243

7.11 International Conference on Harmonization 244

7.12 World Health Organization 245

7.13 Pharmaceutical Inspection Cooperation Scheme 246

7.14 Case Study # 7.1 246

7.15 Case Study # 7.2 249

7.16 Summary of Important Points 250

7.17 Review Questions 251

7.18 Brief Answers and Explanations 251

7.19 Further Reading 252

8 Regulatory Applications 253

8.1 Introduction 253

8.2 United States 254

8.3 European Union 272

8.4 Japan 280

8.5 China 282

8.6 India 287

8.7 Australia 287

8.8 Canada 287

8.9 Case Study #8.1 290

8.10 Case Study #8.2 292

8.11 Summary of Important Points 294

8.12 Review Questions 299

8.13 Brief Answers and Explanations 299

8.14 Further Reading 300

9 Good Manufacturing Practice: Regulatory Requirements 301

9.1 Introduction 301

9.2 United States 302

9.3 Europe 308

9.4 International Conference on Harmonization (ICH) 309

9.5 Pharmaceutical Inspection Cooperation Scheme (PIC/S) 311

9.6 Selected Core Elements of GMP 312

9.7 Selected GMP Sys...

Produktinformationen

Titel: Drugs
Untertitel: From Discovery to Approval
Autor:
Rick Ng
EAN: 9781118907221
ISBN: 978-1-118-90722-1
Digitaler Kopierschutz: Adobe-DRM
Format: E-Book (pdf)
Herausgeber: Wiley-Blackwell
Genre: Mikrobiologie
Anzahl Seiten: 552
Veröffentlichung: 13.04.2015
Jahr: 2015
Auflage: 3. Aufl.
Untertitel: Englisch
Dateigrösse: 12.6 MB