Titlebook: Genotoxicity and Carcinogenicity Testing of Pharmaceuticals; Michael J. Graziano,David Jacobson-Kram Book 2015 Springer International Publ

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enotoxicity and carcinogenicity tests.Written by well recogn.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 cas

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Book 2015es 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

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Book 2015s, 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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https://doi.org/10.1007/978-3-322-98859-1 of findings in the animal studies. This book focuses on these topics in an integrated way, taking into account the rapid advances in safety sciences and evolving regulatory requirements. The book is written by well recognized experts from the pharmaceutical industry and US and European health autho

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https://doi.org/10.1007/978-3-658-09856-8sessment that relies only on knowledge of chemical structure to provide a prediction, making them inexpensive and rapid to apply without the need for synthesis of the potential drug candidate. Toxicogenomic-based approaches aim to assess biological functions based on interactions among various parts

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Die Bedingungen für eine gute Regulirung in vivo . gene mutation assay, and the liver micronucleus (MN) assay. An established test, the transgenic rodent (TGR) gene mutation assay, is presented as a test whose use for regulatory decision-making may increase due to the recent introduction of robust testing protocols and new test guidelines