New edition of succesful standard reference book for the pharmaceutical industry and pharmaceutical physicians! The Textbook of Pharmaceutical Medicine is the coursebook for the Diploma in Pharmaceutical Medicine, and is used as a standard reference throughout the pharmaceutical industry. The new edition includes greater coverage of good clinical practice, a completely revised statistics chapter, and more on safety. Covers the course information for the Diploma in Pharmaceutical Medicine
- Fully updated, with new authors
- Greater coverage of good clinical practice and safety
- New chapters on regulation of medical devices in Europe and regulation of therapeutic products in Australia
Author(s): John P. Griffin, John O'Grady
Edition: 5th ed
Publisher: Blackwell
Year: 2006
Language: English
Pages: 873
City: Oxford; Malden, Mass
Cover......Page 1
The Textbook of Pharmaceutical Medicine, Fifth Edition......Page 2
Copyright......Page 3
Contents......Page 4
Contributors......Page 6
Preface......Page 8
Acknowledgements......Page 9
The Editors......Page 10
Part I Research and Development......Page 12
1 Discovery of New Medicines......Page 13
2 Pharmaceutical Development......Page 97
3 Preclinical Safety Testing......Page 121
4 Exploratory Development......Page 154
5 Clinical Pharmacokinetics......Page 186
6 Purpose and Design of Clinical Trials......Page 208
7 Conduct of Clinical Trials: Good Clinical Practice......Page 249
8 Medical Statistics......Page 285
9 Development of Medicines: Full Development......Page 320
Part II: Medical Department Issues......Page 339
10 The Medical Department......Page 340
11 Medical Marketing......Page 349
12 Information and Promotion......Page 364
13 The Supply of Unlicensed Medicines for Particular Patient Use......Page 389
14 Legal and Ethical Issues Relating to Medicinal Products......Page 399
15 The Safety of Medical Products......Page 419
Part III: Regulatory Aspects......Page 463
16 History of Drug Regulation in the United Kingdom......Page 464
17 Regulation of Human Medicinal Products in the European Union......Page 496
18 European Regulation of Medical Devices......Page 542
19 Technical Requirements for Registration of Pharmaceuticals for Human Use: the ICH Process......Page 559
20 The Regulation of Drug Products by the United States Food and Drug Administration......Page 572
21 The US FDA in the Drug Development, Evaluation and Approval Process......Page 609
22 Past Evolution and Future Prospects of the Pharma Industry and its Regulation in the USA......Page 621
23 Regulatory and Clinical Trial Systems in Japan......Page 644
24 The Regulation of Therapeutic Products in Australia......Page 659
Part IV: Pharmacoeconomic and Other Issues......Page 692
25 Economics of Healthcare......Page 693
26 Controls on NHS Medicines Prescribing and Expenditure in the UK (A Historical Perspective) with some International Comparisons......Page 708
Appendix 1 Declaration of Helsinki......Page 726
Appendix 2 Code of Practice for the Pharmaceutical Industry......Page 732
Appendix 3 Guidelines and Documentation for Implementation of Clinical Trials......Page 792
Appendix 4 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001......Page 831
Index......Page 848
