Téléchargez le livre : Safety Evaluation of Pharmaceuticals and Medical Devices

Safety Evaluation of Pharmaceuticals and Medical Devices

International Regulatory Guidelines

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Éditeur :

Springer


Paru le : 2010-10-26



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Description
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. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Pages
126 pages
Collection
n.c
Parution
2010-10-26
Marque
Springer
EAN papier
9781441974488
EAN EPUB
9781441974495
Informations sur l'ebook
Nombre pages copiables
1
Nombre pages imprimables
12
Taille du fichier
328 Ko
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Prix
147,69 €

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