Nonclinical safety assessment
Subtitle: a guide to international pharmaceutical regulations
By: edited by William J. Brock, Kenneth L. Hastings, and Kathy McGown
Publisher: Wiley
Published: 2013
Place of publication: Chichester, West Sussex
Language: eng
Number of pages: 465
ISBN-13: 9780470745915
Subjects: Methods; International Cooperation; Drug development; Standards; Drug Legislation; Toxicity Tests; Prevention & control; Drug Toxicity; Drug Approval; Preclinical Drug Evaluation; Toxicology; International cooperation; Drugs
Notes: Includes bibliographical references and index.
Table of contents: title: Introduction to the development of drugs / Kathy McGown; title: ICH / Ken Hastings; title: USFDA / Bill Brock; title: Latin America : MERCOSUR countries / Cristiana Leslie Corra; title: Canada / Mark T. Goldberg; title: EMEA / Adam Woolley; title: Africa / Fariza Feraoun; title: China / Lijie Fu; title: Japan / Kazuichi Nakamura; title: India / K.S. Rao; title: Australia / Doug Francis; title: Chronic repeat dose testing / Shana Azri-Meehan; title: Carcinogenicity / James Popp; title: Genotoxicity / Mark Powley; title: Developmental and reproductive toxicology / Robert Parker; title: Juvenile testing and pediatric claim / Melissa Tassinari; title: Immunotoxicology / Leigh Ann Burns Naas; title: Biologics / Chris Ellis; title: Vaccines / Robert House; title: Phototoxicity and photocarcinogenicity / Chris Sambuco; title: Degradants, impurities excipients, and metabolites / Bob Osterberg.