Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 2 скачать в хорошем качестве

Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 2

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 00:59 – Final Guidance: Evaluation of Gastric pH-DDIs With ARAs: Study Design, Data Analysis, & Clinical Implications 23:51 – Q&A Discussion Panel 1 52:09 – Drug-Drug Interaction Assessment for Therapeutic Proteins 01:15:22 – Q&A Discussion Panel 2 Speakers | Panelists: Anuradha Ramamoorthy Policy Lead Guidance & Policy Team Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) CDER | FDA Xinning Yang Policy Lead Guidance & Policy Team OCP | OTS | CDER | FDA Fang Wu Senior Pharmacologist Division of Quantitative Methods and Modeling (DQMM) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) CDER | FDA Insook Kim Master Scientist Division of Inflammation and Immune Pharmacology (DIIP) OCP | OTS | CDER | FDA Lin Zhou Senior Clinical Pharmacologist Division of Cardiometabolic and Endocrine Pharmacology (DCEP) OCP | OTS | CDER | FDA Raajan Naik Policy Analyst Guidance & Policy Team OCP | OTS | CDER | FDA Elimika Pfuma Fletcher Policy Lead Guidance & Policy Team OCP | OTS | CDER | FDA Xiaofei Wang Pharmacologist Division of Clinical Evaluation General Medicine (DCEGM) Office of Therapeutic Products (OTP) Center for Biologics Evaluation and Research (CBER) 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