Genotoxicity and carcinogenicity testing of pharmaceuticals
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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.
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.
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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Taal: en
Bindwijze: Paperback
Oorspronkelijke releasedatum: 13 november 2015
Aantal pagina's: 206
Illustraties: Nee
Hoofdauteur: Graziano Michael J.
Hoofdredacteur: Michael J. Graziano
Tweede Redacteur: David Jacobson-Kram
Hoofduitgeverij: Springer International Publishing Ag
Editie: 1st ed. 2015
Extra groot lettertype: Nee
Product breedte: 155 mm
Product lengte: 235 mm
Studieboek: Nee
Verpakking breedte: 155 mm
Verpakking hoogte: 235 mm
Verpakking lengte: 235 mm
Verpakkingsgewicht: 3736 g
EAN: 9783319220833