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Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
ISBN-13:
9783319220840
Veröffentl:
2015
Seiten:
206
Autor:
Michael J. Graziano
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
1 - PDF Watermark
Sprache:
Englisch
Beschreibung:
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.
¿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.
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