Nonclinical safety assessment : a guide to international pharmaceutical regulations / / edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown.
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| Year of Publication: | 2013 |
| Language: | English |
| Online Access: | |
| Physical Description: | xviii, 465 p. :; ill. |
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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.