Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 1 скачать в хорошем качестве

Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 1

The importance of assessing the drug interactions involving therapeutic protein products, interactions cause by change of gastric pH level, and interactions affecting combined oral contraceptives were discussed during this webinar. Timestamps 01:04 – Overview 06:01 – Health Communications for Optimal Drug Therapy: Examples of Drugs That Interact with CYP Enzymes & Transporter Systems 21:08 – Q&A Discussion Panel 1 48:20 – Clinical Drug Interaction Studies with Combined Oral Contraceptives (COCs) 01:14:28 – Q&A Discussion Panel 2 Speakers | Panelists: Rajanikanth Madabushi Associate Director Guidance & Policy Team Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) CDER | FDA Joseph A. Grillo Associate Director Labeling and Health Communication Team OCP | OTS | CDER | FDA Xinning Yang Policy Lead Guidance & Policy Team OCP | OTS | CDER | FDA Yanhui Lu Team Lead Division of Cardiometabolic and Endocrine Pharmacology (DCEP) OCP | OTS | CDER |FDA Li Li Senior Clinical Pharmacologist DCEP | OCP | OTS | CDER Gerald D Willett Lead Physician Division of Urology, Obstetrics, and Gynecology (DUOG) Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) Office of New Drugs (OND) CDER | FDA 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 2022 Playlist -    • 2022 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