Drugs: from discovery to approval
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Hoboken, NJ
Wiley Blackwell
2015
|
| Ausgabe: | 3. ed. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVI, 536 S. Ill., graph. Darst. |
| ISBN: | 9781118907276 |
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Datensatz im Suchindex
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|---|---|
| adam_text | CONTENTS
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 Tt-ends 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 / 26
2.4 Target Validation / 33
2.5 Drug Interactions with Targets or Receptors / 36
2.6 Enzymes / 40
vfi
viii
CONTENTS
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
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
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
CONTENTS
ix
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
X
CONTENTS
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
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
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
CONTENTS
xi
9.7 Selected GMP Systems / 335
9.8 New cGMP Initiatives / 350
9.9 Case Study #9.1 / 352
9.10 Case Study #9.2 / 358
9.11 Summary of Important Points / 362
9.12 Review Questions / 363
9.13 Brief Answers and Explanations / 363
9.14 Further Reading / 364
10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING 367
10.1 Introduction / 367
10.2 GMP Manufacturing /371
10.3 GMP Inspection / 372
10.4 Manufacture of Small Molecule APIs (Chemical Synthesis
Methods) / 379
10.5 Manufacture of Large Molecule APIs (Recombinant DNA
Methods) / 385
10.6 Finished Dosage Forms / 394
10.7 Product Quality Review / 398
10.8 Manufacturing Variations / 399
10.9 Case Study #10.1 / 400
10.10 Case Study #10.2 / 404
10.11 Summary of Important Points / 407
10.12 Review Questions / 408
10.13 Brief Answers and Explanations / 408
10.14 Further Reading / 408
11 FUTURE PERSPECTIVES 411
11.1 Past Advances and Future Challenges /411
11.2 Small Molecule Pharmaceutical Drugs / 412
11.3 Large Molecule Biopharmaceutical Drugs / 414
11.4 Traditional Medicine / 414
11.5 Personalized Medicine / 419
11.6 Gene Therapy / 420
11.7 Cloning and Stem Ceils / 420
11.8 Old Age Diseases and Aging / 423
11.9 Lifestyle Drugs / 423
11.10 Performance-Enhancing Drugs / 428
11.11 Chemical and Biological Terrorism / 428
xii contents
11.12 Transgenic Animals and Plants / 432
11.13 Antibiotics Drug Resistance / 433
11.14 Regulatory Issues / 435
11.15 Intellectual Property Rights and Marketing Exclusivities / 437
11.16 Bioethics / 440
11.17 Concluding Remarks / 442
11.18 Case Study #11.1 / 445
11.19 Case Study #11.2 / 447
11.20 Further Reading / 449
APPENDIX 1 HISTORY OF DRUG DISCOVERY AND DEVELOPMENT 451
Al.l Early History of Medicine / 451
A1.2 Drug Discovery and Development in the Middle Ages / 453
A1.3 Foundation of Current Drug Discovery and Development / 454
A 1.4 Beginnings of Modern Pharmaceutical Industry / 454
A 1.5 Evolution of Drug Products / 455
A1.6 Further Reading / 456
APPENDIX 2 CELLS, NUCLEIC ACIDS, GENES, AND PROTEINS 457
A2.1 Cells / 457
A2.2 Nucleic Acids / 460
A2.3 Genes and Proteins / 462
A2.4 Further Reading / 468
APPENDIX 3 SELECTED DRUGS AND THEIR MECHANISMS
OF ACTION 469
APPENDIX 4 A DHFR PLASMID VECTOR 481
APPENDIX 5 VACCINE PRODUCTION METHODS 483
APPENDIX 6 VACCINES APPROVED BY FDA 485
APPENDIX 7 PHARMACOLOGY/TOXICOLOGY REVIEW FORMAT 489
APPENDIX 8 EXAMPLES OF GENERAL BIOMARKERS 495
APPENDIX 9 TOXICITY GRADING 499
APPENDIX 10 HEALTH SYSTEMS IN SELECTED COUNTRIES 505
CONTENTS
xiii
ACRONYMS 509
GLOSSARY 515
INDEX 519
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