Nonclinical safety assessment a guide to international pharmaceutical regulations /

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Bibliographic Details
Corporate Author: ebrary, Inc
Other Authors: Brock, William J., Hastings, Kenneth L., McGown, Kathy M.
Format: Electronic eBook
Language:English
Published: Chichester, West Sussex : John Wiley & Sons, 2013.
Subjects:
Online Access:An electronic book accessible through the World Wide Web; click to view
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Table of Contents:
  • Introduction to the development of drugs / Kathy McGown
  • ICH / Ken Hastings
  • USFDA / Bill Brock
  • Latin America : MERCOSUR countries / Cristiana Leslie Corra
  • Canada / Mark T. Goldberg
  • EMEA / Adam Woolley
  • Africa / Fariza Feraoun
  • China / Lijie Fu
  • Japan / Kazuichi Nakamura
  • India / K.S. Rao
  • Australia / Doug Francis
  • Chronic repeat dose testing / Shana Azri-Meehan
  • Carcinogenicity / James Popp
  • Genotoxicity / Mark Powley
  • Developmental and reproductive toxicology / Robert Parker
  • Juvenile testing and pediatric claim / Melissa Tassinari
  • Immunotoxicology / Leigh Ann Burns Naas
  • Biologics / Chris Ellis
  • Vaccines / Robert House
  • Phototoxicity and photocarcinogenicity / Chris Sambuco
  • Degradants, impurities excipients, and metabolites / Bob Osterberg.