Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification

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FDA discusses basic concepts, technical considerations, and best practices for comprehensive reporting of (Q)SAR results and common deficiencies encountered by FDA in regulatory submissions.
Presenter:
Naomi L. Kruhlak, Computational Toxicology Consultation Service (CTCS), Division of Applied Regulatory Science (DARS), Office of Translational Sciences (OTS)

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  
 
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