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

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书目名称Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
编辑Michael J. Graziano,David Jacobson-Kram
视频video
概述Provides context and real case studies to help address critical preclinical safety issues.Provides an overview of alternative and emerging genotoxicity and carcinogenicity tests.Written by well recogn
图书封面Titlebook: Genotoxicity and Carcinogenicity Testing of Pharmaceuticals;  Michael J. Graziano,David Jacobson-Kram Book 2015 Springer International Publ
描述.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. .
出版日期Book 2015
关键词Carcinogenicity; Genotoxicity; Immunomodulators; In Silico Predictive Tests; Regulatory; Tumor Signals
版次1
doihttps://doi.org/10.1007/978-3-319-22084-0
isbn_softcover978-3-319-22083-3
isbn_ebook978-3-319-22084-0
copyrightSpringer International Publishing Switzerland 2015
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Genotoxicity Testing of API,est results usually have severe ramifications with APIs dropped from further development. While negative results in the appropriate follow-up tests (e.g., mouse carcinogenicity studies) could enable progression of API development, pragmatically the cost and long duration required for these tests mea
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Carcinogenicity Testing Strategies for Small Molecules,le pharmaceuticals. Testing strategies for biologic molecules is beyond the scope and the reader is referred to Chap. 8 by Dempster et al. In this chapter a brief history of pharmaceutical carcinogenicity testing is summarized that describes the path of evolution to our current state. The current st
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Nonclinical Strategies for Investigating Potential Tumor Signals Detected in Clinical Trials, of evidence of a carcinogenic risk in nonclinical studies. It is always possible that, given the small numbers of patients in clinical trials, such signals may be due to chance or, for example, ascertainment bias; however, any signal of potential treatment-related malignancy must be evaluated and p
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