Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines - Shayne C. Gad - Books - Springer-Verlag New York Inc. - 9781441974488 - October 27, 2010
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Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines 2011 edition

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The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force.


140 pages, 2 colour illustrations, 48 black & white tables, 1 colour tables, biography

Media Books     Hardcover Book   (Book with hard spine and cover)
Released October 27, 2010
ISBN13 9781441974488
Publishers Springer-Verlag New York Inc.
Pages 126
Dimensions 155 × 235 × 13 mm   ·   267 g
Language English  

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