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.
Nyckelord: 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
- Utgivare
- Brock, William J.
- Hastings, Kenneth L.
- McGown, Kathy M.
- Utgivare
- John Wiley and Sons, Inc.
- Utgivningsår
- 2013
- Språk
- en
- Utgåva
- 1
- Sidantal
- 488 sidor
- Kategori
- Hälsa, skönhet, mode
- Format
- E-bok
- eISBN (ePUB)
- 9781118516980
- Tryckt ISBN
- 9780470745915