Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices / by John J. Tobin, Gary Walsh.
Material type: TextPublication details: Weinheim : Wiley-VCH ; Chichester : John Wiley [distributor], 2008.Description: 260 pISBN:- 9783527318773 (hbk.) :
- 9783527318773 (hbk.) :
- 344.0416 TOB
- K3636
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.