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Tobin, Jack

Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices / John J. Tobin and Gary Walsh. - [Weinheim] : Wiley-Blackwell ; Wiley-VCH Verlag, c2008. - xiii, 283 p. : ill. ; 25 cm.

Includes bibliographical references and index.

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.

ISBN: 9783527318773 3527318771 9783527318773: £50.00

Subjects--Topical Terms:
Drugs--Law and legislation
Pharmacy--Law and legislation
Medical instruments and apparatus--Law and legislation
Pharmacology
Health systems & services
Public health & safety law
Medical specialties, branches of medicine
Jurisprudence & general issues
Biology, life sciences
Public health & preventive medicine

Dewey Class. No.: 344.0416