A Textbook of Pharmaceutical Medicine / Edition 1

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Product Details

  • ISBN-13: 9781850703419
  • Publisher: CRC Press
  • Publication date: 3/1/1993
  • Edition description: New Edition Due
  • Edition number: 1
  • Pages: 461

Table of Contents

List of contributors
Preface
1 The historical development of medicines regulations 3
2 History: experimental therapeutics 13
3 Drug development 19
4 Strategy and choice of research and development projects 41
5 Chemistry in the development of new drugs 53
6 Biochemistry and pharmacology 63
7 Pharmacy and pharmaceutical development 85
8 Toxicology and safety assessment 95
9 The Clinical Development Plan 111
10 Clinical pharmacology - pharmacodynamics 129
11 Clinical pharmacokinetics 143
12 The management of clinical trials 151
13 Assessment of new therapeutic effects 169
14 Good Clinical Practice 179
15 Preparing the Marketing Authorization Application 195
16 Clinical trials data management 207
17 Statistical methods for clinical trials: fundamentals 213
18 Decision theory and its relevance to pharmaceutical medicine 247
19 The regulation of medicines in Europe 259
20 The United States regulatory system 269
21 Perhaps peripheral - but significant 277
22 Phase IV studies and post-marketing surveillance 283
23 The medical contribution to marketing a new medicine 287
24 Product information 295
25 Management of international clinical trial programmes 309
26 Monitoring adverse events and reactions 317
27 Spontaneous adverse drug reaction reporting systems 323
28 Case-control studies 331
29 Cohort studies 337
30 Advertising and promotion of pharmaceuticals: the role of the pharmaceutical physician 345
31 The Code of Practice for the Pharmaceutical Industry 353
32 Ethical and medicolegal issues 357
33 Fraud and misconduct in clinical research 367
34 The evolution of health care systems: an economic approach 381
35 Health economics 391
36 Drug policy 415
37 Structure of the pharmaceutical industry 423
38 The pharmaceutical market 437
Appendix I IFPMA Code of Pharmaceutical Marketing Practices 447
Appendix II World Medical Association Declaration of Helsinki 451
Index 455
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