Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification скачать в хорошем качестве

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) Learn more at: https://www.fda.gov/drugs/news-events... --------------------  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.     Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367