Brock, William J.
Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations
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.
Keywords: Nonclinical Safety Assessment, William Brock, Kenneth Hastings, drug safety, World Health Organization, WHO, EMEA guidance, U.S. FDA, ICH, Toxicology, Intellectual Property Law, Toxicology, Intellectual Property Law
- Editor
- Brock, William J.
- Hastings, Kenneth L.
- McGown, Kathy M.
- Publisher
- John Wiley and Sons, Inc.
- Publication year
- 2013
- Language
- en
- Edition
- 1
- Page amount
- 488 pages
- Category
- Medicine, Health Care, Mode
- Format
- Ebook
- eISBN (ePUB)
- 9781118516980
- Printed ISBN
- 9780470745915