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Nonclinical Safety Assessment

A Guide to International Pharmaceutical Regulations

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Éditeur :

Wiley


Paru le : 2013-02-20



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Description
Nonclinical Safety Assessment
Nonclinical Safety Assessment
A Guide to International Pharmaceutical Regulations
Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions.
It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites
Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Pages
496 pages
Collection
n.c
Parution
2013-02-20
Marque
Wiley
EAN papier
9780470745915
EAN PDF
9781118517017
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
496
Taille du fichier
13455 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
183,86 €
EAN EPUB
9781118516980
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
496
Taille du fichier
2673 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
183,86 €

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