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Genotoxicity and carcinogenicity tes...

Graziano, Michael J.

Genotoxicity and carcinogenicity testing of pharmaceuticals

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Genotoxicity and carcinogenicity testing of pharmaceuticalsedited by Michael J. Graziano, David Jacobson-Kram.
其他作者:	Graziano, Michael J.
出版者:	Cham :Springer International Publishing :2015.
面頁冊數:	x, 206 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
標題:	Genetic toxicology.
電子資源:	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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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.
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