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Genotoxicity and carcinogenicity tes...

Graziano, Michael J.

Genotoxicity and carcinogenicity testing of pharmaceuticals

Record Type:	Electronic resources : Monograph/item
Title/Author:	Genotoxicity and carcinogenicity testing of pharmaceuticalsedited by Michael J. Graziano, David Jacobson-Kram.
other author:	Graziano, Michael J.
Published:	Cham :Springer International Publishing :2015.
Description:	x, 206 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
Subject:	Genetic toxicology.
Online resource:	http://dx.doi.org/10.1007/978-3-319-22084-0
ISBN:	9783319220840$q(electronic bk.)

Genotoxicity and carcinogenicity testing of pharmaceuticals
Genotoxicity and carcinogenicity testing of pharmaceuticals[electronic resource] /edited by Michael J. Graziano, David Jacobson-Kram. - Cham :Springer International Publishing :2015. - x, 206 p. :ill., digital ;24 cm.

Introduction -- History and Current Regulatory Requirements -- Genotoxicity Testing of API and Impurities -- New Emerging Genotoxicity Tests -- Carcinogenicity Testing of Small Molecules -- Alternatives to the 2-Year Rodent Studies -- Addressing Positive Findings in Carcinogenicity Studies -- Investigating Tumor Signals in Clinical Trials -- Tumor Promoters -- Carcinogenicity Testing of Biologics -- In Silico Predictive Tests.

This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.

ISBN: 9783319220840$q(electronic bk.)

Standard No.: 10.1007/978-3-319-22084-0doiSubjects--Topical Terms:

188807
Genetic toxicology.

LC Class. No.: RC268.65

Dewey Class. No.: 616.994071

Genotoxicity and carcinogenicity testing of pharmaceuticals
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245 0 0 $a Genotoxicity and carcinogenicity testing of pharmaceuticals $h [electronic resource] / $c edited by Michael J. Graziano, David Jacobson-Kram.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2015.
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505 0 $a Introduction -- History and Current Regulatory Requirements -- Genotoxicity Testing of API and Impurities -- New Emerging Genotoxicity Tests -- Carcinogenicity Testing of Small Molecules -- Alternatives to the 2-Year Rodent Studies -- Addressing Positive Findings in Carcinogenicity Studies -- Investigating Tumor Signals in Clinical Trials -- Tumor Promoters -- Carcinogenicity Testing of Biologics -- In Silico Predictive Tests.
520 $a This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.
650 0 $a Genetic toxicology. $3 188807
650 0 $a Carcinogenicity testing. $3 302487
650 1 4 $a Biomedicine. $3 273648
650 2 4 $a Cancer Research. $3 273660
650 2 4 $a Pharmaceutical Sciences/Technology. $3 338426
700 1 $a Graziano, Michael J. $3 730934
700 1 $a Jacobson-Kram, David. $3 730935
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer eBooks
856 4 0 $u http://dx.doi.org/10.1007/978-3-319-22084-0
950 $a Biomedical and Life Sciences (Springer-11642)