Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations
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Other Available Formats: E-book
- 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.