Nonclinical Safety Assessment

A Guide to International Pharmaceutical Regulations

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Nonclinical Safety Assessment by , Wiley
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9781118516980
Publisher: Wiley Publication: March 5, 2013
Imprint: Wiley Language: English
Author:
ISBN: 9781118516980
Publisher: Wiley
Publication: March 5, 2013
Imprint: Wiley
Language: English

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*.*

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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:

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*.*

More books from Wiley

Cover of the book Elements of Modern X-ray Physics by
Cover of the book Principles of Urban Retail Planning and Development by
Cover of the book Alts Democratized by
Cover of the book Questions and Answers in Small Animal Anesthesia by
Cover of the book Applications of Flow Cytometry in Stem Cell Research and Tissue Regeneration by
Cover of the book Meet and Grow Rich by
Cover of the book Wiley Series 6 Securities Licensing Exam Review 2019 + Test Bank by
Cover of the book Complete B2B Online Marketing by
Cover of the book Humanizing the Education Machine by
Cover of the book Lighting Design Basics by
Cover of the book Galatians Through the Centuries by
Cover of the book A Companion to Renaissance and Baroque Art by
Cover of the book ABC of Emergency Radiology by
Cover of the book QOS-Enabled Networks by
Cover of the book Lead Positive by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy