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.
Avainsanat: 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
- Toimittaja
- Brock, William J.
- Hastings, Kenneth L.
- McGown, Kathy M.
- Julkaisija
- John Wiley and Sons, Inc.
- Julkaisuvuosi
- 2013
- Kieli
- en
- Painos
- 1
- Sivumäärä
- 488 sivua
- Kategoria
- Terveys, kauneus, muoti
- Tiedostomuoto
- E-kirja
- eISBN (ePUB)
- 9781118516980
- Painetun ISBN
- 9780470745915