Preclinical and Translational Sciences
Jim Herman, PhD, DABT (1992-2022)
Vice President
Certara
Ann Arbor, Michigan
Description: Since the adoption of ICHQ3 under Step 3 in March 1995, the expectation for qualification studies to support specification limits has consisted of genotoxicity studies of 14 to 90 days duration, as well as an assessment of other specific toxicity endpoints as appropriate. Since that time, hundreds if not thousands of studies, with thousands if not tens of thousands of animals have been conducted. Such studies rarely demonstrate a change in the toxicologic profile of the active pharmaceutical ingredient (API) that would represent a clinical risk. Rising costs, limited availability of some animal species, the emphasis on the 3R’s (reduce, refine, replace) in animal testing, advances in in silico and in vitro technologies, improved understanding of mechanisms of biologic activity, and the need for timely qualification data indicate that it is time to consider alternative approaches to standard studies to qualify impurities/degradation products.
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