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Brock, William J. | McGown, Kathy M. | Hastings, Kenneth L.

Nonclinical Safety Assessment : A Guide to International Pharmaceutical Regulations

2013 - John Wiley et Sons Ltd.

496 p.

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. [Publisher's Text]

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