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 UseNational regulations, including US FDA, Canada, Mercosur
and Brazil, South Africa, China, Japan, India and AustraliaRepeated
dose toxicity studiesCarcinogenicity; Genotoxicity; Developmental
and reproductive toxicology; ImmunotoxicologyBiotechnology-derived
pharmaceuticalsVaccine developmentPhototoxicity and
photocarcinogenicityDegradants, 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.""
General
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