Module 5 Presentations

16/07/2024

The Guidelines that help manage risks…..

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The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

15

GENETIC TOXICITY - ICH S2(R1) Nov 2011

No single test is capable of examining all endpoints – Use a Test Battery

• In vitro and in vivo tests to detect compounds that induce genetic damage by various mechanisms. • To enable hazard identification with respect to damage to DNA and its fixation… • …generally considered to be essential for heritable effects and can be part of the multi-step process of malignancy Genetic Toxicology - ICH S2 R1

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

16

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