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9780727917805

Regulation of Medical Products

by ;
  • ISBN13:

    9780727917805

  • ISBN10:

    0727917803

  • Edition: 1st
  • Format: Paperback
  • Copyright: 2003-04-11
  • Publisher: BMJ Books

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Summary

A concise but comprehensive text explaining the processes involved in regulation of drugs with particular emphasis on EU, USA and Australia.

Author Biography

John Griffin is the editor of Regulation of Medical Products, published by Wiley.

John O'Grady is the editor of Regulation of Medical Products, published by Wiley.

Table of Contents

Contributors v
Preface vii
Acknowledgements viii
The editors ix
History of drug regulation in the UK
1(38)
Rashmi R Shah
John P Griffin
Regulation of human medicinal products in the European Union
39(44)
Rashmi R Shah
John P Griffin
European regulation of medical devices
83(26)
Christopher Hodges
The supply of unlicensed medicines for particular patient use
109(12)
John O'Grady
Amanda Wearing
Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective)
121(21)
John P Griffin
Jane R Griffin
The regulation of therapeutic products in Australia
142(43)
Janice Hirshorn
Deborah Monk
Regulatory and clinical trial systems in Japan
185(24)
Yuichi Kubo
John O'Grady
The regulation of drug products by the United States Food and Drug Administration
209(50)
Peter Barton Hutt
The US FDA in the drug development, evaluation, and approval process
259(17)
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
276(17)
Patrick F D'Arcy
Dean WG Harron
Appendix 1: European guidelines relevant for pharmaceutical physicians 293(6)
Index 299

Supplemental Materials

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

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