Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

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 i...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Graziano, Michael J. (Editor ), Jacobson-Kram, David (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cham : Springer International Publishing : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Temas:
Cancer.
Pharmaceutical chemistry.
Cancer Biology.
Pharmaceutics.
Acceso en línea:Texto Completo

MARC

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245 1 0 |a Genotoxicity and Carcinogenicity Testing of Pharmaceuticals  |h [electronic resource] /  |c edited by Michael J. Graziano, David Jacobson-Kram. 
250 |a 1st ed. 2015. 
264 1 |a Cham :  |b Springer International Publishing :  |b Imprint: Springer,  |c 2015. 
300 |a X, 206 p. 15 illus., 8 illus. in color.  |b online resource. 
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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 Cancer. 
650 0 |a Pharmaceutical chemistry. 
650 1 4 |a Cancer Biology. 
650 2 4 |a Pharmaceutics. 
700 1 |a Graziano, Michael J.  |e editor.  |4 edt  |4 http://id.loc.gov/vocabulary/relators/edt 
700 1 |a Jacobson-Kram, David.  |e editor.  |4 edt  |4 http://id.loc.gov/vocabulary/relators/edt 
710 2 |a SpringerLink (Online service) 
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950 |a Biomedical and Life Sciences (SpringerNature-11642) 
950 |a Biomedical and Life Sciences (R0) (SpringerNature-43708) 

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