In this presentation, Dr. Naomi Kruhlak of US FDA CDER investigates the impact of expert review on ICH M7 QSAR Predictions: Is Expert Review Still Needed?
The ICH M7 guideline recommends the use of complementary (Q)SAR models to assess the mutagenic potential of drug impurities as an alternative to empirical testing. The guideline also includes a provision for the application of expert knowledge to increase prediction confidence and resolve conflicting calls. Expert knowledge, which considers structural analogs and mechanisms of activity, has been valuable when models return an indeterminate (equivocal) result or no prediction (out-of-domain).
Dr. Naomi Kruhlak of US FDA CDER summarizes a recent study which examined the impact of expert review on (Q)SAR predictions. Open Source Link: www.sciencedir...
The presentation will review findings that include the rates of overturned calls, the category (equivocal/positive, or equivocal/negative) to which it belonged, and the chemical classes which were subject to the highest rates of overturns as a result of applying expert review.
3 окт 2024
