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

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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