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The Textbook of Pharmaceutical Medicine is a standard reference for pharmaceutical medicine. This comprehensive volume covers the processes by which medicines are developed, tested and approved. Regulations for drug development in the UK, EU, USA, Australia and Japan are discussed, providing relevant information for drug approval in the main continents where new drugs are developed. The chapters are written by leading academics, medical directors and lawyers, providing authoritative and in-depth information for trainees on the Faculty course, and for physicians in the pharmaceutical industry.

 

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Part I: Research and development.

 

Introduction: the development of pharmaceutical medicine as a specialty.

 

1 Discovery of new medicines.

 

2 Pharmaceutical development.

 

3 Preclinical safety testing.

 

4 Exploratory development.

 

5 Clinical pharmacokinetics.

 

6 Purpose and design of clinical trials.

 

7 Conduct of clinical trials: good clinical practice.

 

8 Medical statistics.

 

9 Development of medicines: full development.

 

Part II: Medical department issues.

 

10 The medical department.

 

11 Medical marketing.

 

12 Information and promotion.

 

13 The supply of unlicensed medicines for particular patient use.

 

14 Ethics of human experimentation.

 

15 Legal and ethical issues relating to medicinal products.

 

16 The safety of medical products.

 

Part III: Regulatory aspects.

 

17 History of drug regulation in the United Kingdom.

 

18 Regulation of human medicinal products in the European Union.

 

19 Paediatric regulation.

 

20 European regulation of medical devices.

 

21 Technical requirements for registration of pharmaceuticals for human use: the ICH process.

 

22 The regulation of drug products by the United States Food and Drug Administration.

 

23 The US FDA in the drug development, evaluation and approval process.

 

24 Past evolution and future prospects of the Pharma Industry and its regulation in the USA.

 

25 Regulatory and clinical trial systems in Japan.

 

26 The regulation of therapeutic products in Australia.

 

27 Pharmaceutical medicine in emerging markets.

 

Part IV: Pharmacoeconomic and other issues.

 

28 Economics of healthcare.

 

29 Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) with some international comparisons.

 

30 Due diligence and the pharmaceutical physician.

 

Appendix 1 Declaration of Helsinki.

 

Appendix 2 Code of Practice for the Pharmaceutical Industry.

 

Appendix 3 Guidelines and Documentation for Implementation of Clinical Trials.

 

Appendix 4 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001