 The Textbook of Pharmaceutical Medicine, 5th Edition
ISBN: 978-0-7279-1840-6
Hardcover
880 pages
February 2006, BMJ Books
US $221.95
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Part I: Research and development.
1 Discovery of new medicines .
Anand S Dutta.
2 Pharmaceutical development .
Gavin Halbert.
3 Preclinical safety testing .
David J Tweats.
4 Exploratory development .
John Posner.
5 Clinical pharmacokinetics .
Paul Rolan and Valeria Molnar.
6 Purpose and design of clinical trials .
Roger A Yates.
7 Conduct of clinical trials: good clinical practice .
Roger A Yates.
8 Medical statistics .
Andrew P Grieve.
9 Development of medicines: full development .
Alan G Davies and Peter D Stonier.
Part II: Medical department issues.
10 The medical department .
Darrall L Higson (with revisions by Peter D Stonier).
11 Medical marketing .
John H Young.
12 Information and promotion .
D Michael Humphreys.
13 The supply of unlicensed medicines for particular patient use .
Amanda Wearing and John O' Grady.
14 Legal and ethical issues relating to medicinal products .
Christine H Bendall and Christopher JS Hodges.
15 The safety of medical products .
A Peter Fletcher and Susan Shaw.
Part III: Regulatory aspects.
16 History of drug regulation in the United Kingdom .
John P Griffin and Rashmi R Shah.
17 Regulation of human medicinal products in the European Union.
Rashmi R Shah and John P Griffin.
18 European regulation of medical devices .
Christopher JS Hodges.
19 Technical requirements for registration of pharmaceuticals for human use: the ICH process.
Dean W G Harron.
20 The regulation of drug products by the United States Food and Drug Administration.
Peter Barton Hutt.
21 The US FDA in the drug development, evaluation and approval process.
Richard N Spivey, Judith K Jones, WilliamW ardell and WilliamV odra.
22 Past evolution and future prospects of the Pharma Industry and its regulation in the USA.
WilliamW ardell, WilliamV odra, Judith K Jones and Richard N Spivey.
23 Regulatory and clinical trial systems in Japan.
Yuichi Kubo.
24 The regulation of therapeutic products in Australia.
Janice Hirshorn and Deborah Monk.
Part IV: Pharmacoeconomic and other issues.
25 Economics of healthcare.
Carole Bradley and Jane R Griffin.
26 Controls on NHS medicines prescribing and expenditure in the.
UK (a historical perspective) with some international comparisons.
John P Griffin and Jane R Griffin.
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.
Index
1 Discovery of new medicines .
Anand S Dutta.
2 Pharmaceutical development .
Gavin Halbert.
3 Preclinical safety testing .
David J Tweats.
4 Exploratory development .
John Posner.
5 Clinical pharmacokinetics .
Paul Rolan and Valeria Molnar.
6 Purpose and design of clinical trials .
Roger A Yates.
7 Conduct of clinical trials: good clinical practice .
Roger A Yates.
8 Medical statistics .
Andrew P Grieve.
9 Development of medicines: full development .
Alan G Davies and Peter D Stonier.
Part II: Medical department issues.
10 The medical department .
Darrall L Higson (with revisions by Peter D Stonier).
11 Medical marketing .
John H Young.
12 Information and promotion .
D Michael Humphreys.
13 The supply of unlicensed medicines for particular patient use .
Amanda Wearing and John O' Grady.
14 Legal and ethical issues relating to medicinal products .
Christine H Bendall and Christopher JS Hodges.
15 The safety of medical products .
A Peter Fletcher and Susan Shaw.
Part III: Regulatory aspects.
16 History of drug regulation in the United Kingdom .
John P Griffin and Rashmi R Shah.
17 Regulation of human medicinal products in the European Union.
Rashmi R Shah and John P Griffin.
18 European regulation of medical devices .
Christopher JS Hodges.
19 Technical requirements for registration of pharmaceuticals for human use: the ICH process.
Dean W G Harron.
20 The regulation of drug products by the United States Food and Drug Administration.
Peter Barton Hutt.
21 The US FDA in the drug development, evaluation and approval process.
Richard N Spivey, Judith K Jones, WilliamW ardell and WilliamV odra.
22 Past evolution and future prospects of the Pharma Industry and its regulation in the USA.
WilliamW ardell, WilliamV odra, Judith K Jones and Richard N Spivey.
23 Regulatory and clinical trial systems in Japan.
Yuichi Kubo.
24 The regulation of therapeutic products in Australia.
Janice Hirshorn and Deborah Monk.
Part IV: Pharmacoeconomic and other issues.
25 Economics of healthcare.
Carole Bradley and Jane R Griffin.
26 Controls on NHS medicines prescribing and expenditure in the.
UK (a historical perspective) with some international comparisons.
John P Griffin and Jane R Griffin.
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.
Index
