Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices / John J. Tobin and Gary Walsh.
2008
K3636 .T63 2008 (Mapit)
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Author
Title
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices / John J. Tobin and Gary Walsh.
Imprint
[Weinheim] : Wiley-Blackwell : Wiley-VCH Verlag, [2008]
Copyright
©2008
Description
xiii, 283 pages : illustrations ; 25 cm
Formatted Contents Note
The aims and structure of regulations
Regulatory strategy
Drug discovery and development
Non-clinical studies
Clinical trials
Marketing authorisation
Authorisation of veterinary medicines
Variations to the drug authentication process
Medical devices
Authorisation of medical devices
Good manufacturing practice (GMP)
Oversight and vigilance.
Regulatory strategy
Drug discovery and development
Non-clinical studies
Clinical trials
Marketing authorisation
Authorisation of veterinary medicines
Variations to the drug authentication process
Medical devices
Authorisation of medical devices
Good manufacturing practice (GMP)
Oversight and vigilance.
Bibliography, etc. Note
Includes bibliographical references and index.
Location
STA
Call Number
K3636 .T63 2008
Language
English
ISBN
9783527318773 hardback
3527318771 hardback
3527318771 hardback
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