Login

Brock, William

Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations

Brock, William - Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations, ebook

172,50€

Ebook, ePUB with Adobe DRM
ISBN: 9781118516980
DRM Restrictions

Printing146 pages with an additional page accrued every 5 hours, capped at 146 pages
Copy to clipboard5 excerpts

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 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: Drug Discovery & Development, Nonclinical Safety Assessment, William Brock, Kenneth Hastings, drug safety, World Health Organization, WHO, EMEA guidance, U.S. FDA, ICH

Author(s)
 
 
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

Similar titles