ICH M12 Drug-Drug Interaction Studies Final Guidance скачать в хорошем качестве

ICH M12 Drug-Drug Interaction Studies Final Guidance

This webinar discussed the ICH M12 Drug Interaction Studies guidance which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. The discussion included content related to the full scope of the guidance: in vitro evaluations, clinical studies, predictive modeling, study interpretation, risk assessment, and risk management. Timestamps 01:00 – ICH M12 Drug Interaction Studies Final Guidance 08:58 – ICH M12 Drug Interaction Final Guidance – In Vitro DDI Assessments 40:41 – Q&A Session 1 57:51 – ICH M12 Drug Interaction Final Guidance – Clinical DDI Assessments 01:20:22 – Q&A Session 2 Speakers | Panelists: Kellie Reynolds, Pharm.D. Director Division of Infectious Disease Pharmacology (DIDP) Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) | CDER Xinning Yang, Ph.D. Policy Lead Guidance & Policy Team OCP | OTS | CDER Helen Heymann, MMSc, PMP, CPH Regulatory Health Project Manager Executive Program and Project Management Staff OCP | OTS | CDER Rajanikanth Madabushi, Ph.D. Associate Director Guidance & Policy Team OCP | OTS | CDER 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 2024 Playlist -    • 2024 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 - [email protected] Phone - (301) 796-6707 I (866) 405-5367