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

By: Material type: TextTextPublication details: Weinheim : Wiley-VCH ; Chichester : John Wiley [distributor], 2008.Description: 260 pISBN:
  • 9783527318773 (hbk.) :
  • 9783527318773 (hbk.) :
Subject(s): DDC classification:
  • 344.0416 TOB
LOC classification:
  • K3636
Contents:
1.The aims and structure of regulations -- 2.Regulatory strategy -- 3.Drug discovery and development -- 4.Non-cliinical studies -- 5.Clinical trials -- 6.Marketing authorisation -- 7.Authorisation of veterinary medicines -- 8.Variations to the drug authorisation process -- 9.Medical devices -- 10.Authorisation of medical devices -- 11.Good manufacturing practice (GMP) -- 12.Oversight and vigilance.
Summary: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Long Loan TUS: Midlands, Main Library Athlone General Lending 344.0416 TOB (Browse shelf(Opens below)) 1 Available 216679
Long Loan TUS: Midlands, Main Library Athlone General Lending 344.0416 TOB (Browse shelf(Opens below)) 1 Available 207656

Includes bibliographical references and index.

1.The aims and structure of regulations -- 2.Regulatory strategy -- 3.Drug discovery and development -- 4.Non-cliinical studies -- 5.Clinical trials -- 6.Marketing authorisation -- 7.Authorisation of veterinary medicines -- 8.Variations to the drug authorisation process -- 9.Medical devices -- 10.Authorisation of medical devices -- 11.Good manufacturing practice (GMP) -- 12.Oversight and vigilance.

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.

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