A Textbook of Pharmaceutical Medicine / Edition 1

A Textbook of Pharmaceutical Medicine / Edition 1

by R. E. Mann

Product Details

CRC Press
Publication date:
Edition description:
New Edition Due

Table of Contents

List of contributors
1The historical development of medicines regulations3
2History: experimental therapeutics13
3Drug development19
4Strategy and choice of research and development projects41
5Chemistry in the development of new drugs53
6Biochemistry and pharmacology63
7Pharmacy and pharmaceutical development85
8Toxicology and safety assessment95
9The Clinical Development Plan111
10Clinical pharmacology - pharmacodynamics129
11Clinical pharmacokinetics143
12The management of clinical trials151
13Assessment of new therapeutic effects169
14Good Clinical Practice179
15Preparing the Marketing Authorization Application195
16Clinical trials data management207
17Statistical methods for clinical trials: fundamentals213
18Decision theory and its relevance to pharmaceutical medicine247
19The regulation of medicines in Europe259
20The United States regulatory system269
21Perhaps peripheral - but significant277
22Phase IV studies and post-marketing surveillance283
23The medical contribution to marketing a new medicine287
24Product information295
25Management of international clinical trial programmes309
26Monitoring adverse events and reactions317
27Spontaneous adverse drug reaction reporting systems323
28Case-control studies331
29Cohort studies337
30Advertising and promotion of pharmaceuticals: the role of the pharmaceutical physician345
31The Code of Practice for the Pharmaceutical Industry353
32Ethical and medicolegal issues357
33Fraud and misconduct in clinical research367
34The evolution of health care systems: an economic approach381
35Health economics391
36Drug policy415
37Structure of the pharmaceutical industry423
38The pharmaceutical market437
Appendix I IFPMA Code of Pharmaceutical Marketing Practices447
Appendix II World Medical Association Declaration of Helsinki451

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