Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

• Corporate Author: SpringerLink (Online service)
• Other Authors: Graziano, Michael J. (Editor), Jacobson-Kram, David (Editor)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2015.
• Edition: 1st ed. 2015.
• Subjects: Medicine.; Cancer research.; Pharmaceutical technology.; Biomedicine.; Cancer Research.; Pharmaceutical Sciences/Technology.

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 i...

Table of Contents:

• 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.