Bookedited by William J. Brock, Kenneth L. Hastings, and Kathy McGown.
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.