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

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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