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" The regulation of medical products / "
edited by J.P. Griffin and J. O'Grady.
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BL
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| Record Number
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990750
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b745120
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| Title & Author
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The regulation of medical products /\ edited by J.P. Griffin and J. O'Grady.
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| Publication Statement
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London :: BMJ Books,, ©2003.
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| Page. NO
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1 online resource (x, 310 pages) :: illustrations
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| ISBN
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0585444021
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: 0727917803
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: 9780585444024
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: 9780727917805
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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History of drug regulation in the UK / Rashmi R. Shah, John P. Griffin -- Regulation of human medicinal products in the European Union / Rashmi R. Shah, John P. Griffin -- European regulation of medical devices / Christopher Hodges -- The supply of unlicensed medicines for particular patient use / John O'Grady, Amanda Wearing -- Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective) / John P. Griffin, Jane R. Griffin -- The regulation of therapeutic products in Australia / Janice Hirshorn, Deborah Monk -- Regulatory and clinical trial systems in Japan / Yuichi Kubo, John O'Grady -- The regulation of drug products by the United States Food and Drug Administration / Peter Barton Hutt -- The US FDA in the drug development, evaluation, and approval process / Richard N. Spivey, Louis Lasagna, Judith K. Jones, William Wardell -- Technical requirements for registration of pharmaceuticals for human use: the ICH process and the Common Technical Document / Patrick F. D'Arcy, Dean W.G. Harron -- Appendix 1: European guidelines relevant for pharmaceutical physicians.
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| Abstract
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Understanding the licensing of medical products is fast becoming a requirement in clinical medicine. This text, written by specialists but tailored to the needs of the practising physician and pharmacist, explains the processes and regulations in the major drug producing countries.
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| Subject
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Drugs-- Law and legislation-- Great Britain.
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Pharmacy-- Law and legislation-- Great Britain.
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Drugs-- Law and legislation.
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LAW-- Medical Law Legislation.
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Pharmacy-- Law and legislation.
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Great Britain.
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| Dewey Classification
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344/.0416
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| LC Classification
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KD3460.A73 2003eb
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| Added Entry
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Griffin, J. P., (John Parry)
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O'Grady, John,1944-
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