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Nonclinical safety assessment :a gui...

Hastings, Kenneth L.

Nonclinical safety assessment :a guide to international pharmaceutical regulations /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Nonclinical safety assessment :/ edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown.
其他題名:	a guide to international pharmaceutical regulations /
其他作者:	McGown, Kathy.
出版者:	Chichester, West Sussex, U.K. :Wiley, : c2013.,
面頁冊數:	xviii, 465 p., [4] p. of plates :ill. (some col.) ; : 26 cm.;
標題:	Toxicity Tests - standards. -
ISBN:	9780470745915 (hard) :

Nonclinical safety assessment :a guide to international pharmaceutical regulations /
Nonclinical safety assessment :a guide to international pharmaceutical regulations /edited by William J. Brock, Kenneth L. Hastings, Kathy M. McGown. - Chichester, West Sussex, U.K. :Wiley,c2013. - xviii, 465 p., [4] p. of plates :ill. (some col.) ;26 cm.

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.

ISBN: 9780470745915 (hard) :NT5886

LCCN: 2012037888Subjects--Topical Terms:

351590
Toxicity Tests
--standards.

LC Class. No.: RM301.25 / .N64 2013

Dewey Class. No.: 615.1/901

National Library of Medicine Call No.: QV 771

Nonclinical safety assessment :a guide to international pharmaceutical regulations /
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504 $a Includes bibliographical references and index.
505 0 $a 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.
650 2 2 $a Toxicity Tests $x standards. $3 351590
650 2 2 $a Legislation, Drug. $3 351589
650 2 2 $2 96060 $a International Cooperation. $3 243046
650 2 2 $a Drug Toxicity $x prevention & control. $3 351588
650 2 2 $2 96060 $a Drug Approval $x methods. $3 240237
650 1 2 $a Drug Evaluation, Preclinical $x standards. $3 351587
650 0 $a Drugs $x Toxicology $x International cooperation. $3 351586
650 0 $a Drug development $x International cooperation. $3 351585
700 1 $a McGown, Kathy. $3 351584
700 1 $a Hastings, Kenneth L. $3 351583
700 1 $a Brock, William J. $3 351582