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Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices / John J. Tobin and Gary Walsh.

By: Material type: TextTextPublication details: [Weinheim] : Wiley-Blackwell ; Wiley-VCH Verlag, c2008.Description: xiii, 283 p. : ill. ; 25 cmISBN:
  • 9783527318773
  • 3527318771
  • 9783527318773:
Subject(s): DDC classification:
  • 344.0416
Contents:
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.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
General Lending Carlow Campus Library General Lending 344.0416 (Browse shelf(Opens below)) 1 Available 79411
General Lending Carlow Campus Library General Lending 344.0416 (Browse shelf(Opens below)) 1 Available 79410

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.

77.21

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