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Nonclinical safety assessment：a guide to international pharmaceutical regulations

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Bibliographic Details
Group Author: Brock William J.; Hastings Kenneth L.; McGown Kathy M.
Published: Wiley,
Publisher Address: Chichester, West Sussex
Publication Dates: 2013.
Literature type: Book
Language: English
Subjects:
Drug development > International cooperation.
Drugs > Toxicology > International cooperation.
Drug Evaluation, Preclinical > standards.
Drug Approval > methods.
Drug Toxicity > prevention & control
International cooperation.
Legislation, Drug
Toxicity Tests > standards.
Carrier Form: xviii, 465 p., [4] p. of plates: ill. (some col. ); ; 25 cm.
ISBN: 9780470745915 (cloth)
0470745916 (cloth)
Index Number: R951
CLC: R951
Call Number: R951/N812
Contents: Includes bibliographical references and index.
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.

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