GDF2025 - D2S01- General Quality Considerations of Drug Products Labeled for Alternate Dosing скачать в хорошем качестве

GDF2025 - D2S01- General Quality Considerations of Drug Products Labeled for Alternate Dosing

This presentation provided an overview of general quality considerations of Drug Product Labeled for Alternate Dosing Administration such as product administered by use of vehicles after crushing or sprinkling, via in-vitro feeding tube, etc. The presentation covered relevant FDA Guidances along with quality information in generic drug applications. Timestamps 02:35 – Products Labeled for Alternate Administration 08:16 – Quality information 09:15 – Case studies 20:06 – Summary Speaker: Ravikanth Kona, PhD Pharmaceutical Scientist Division of Product Quality Assessment I (DPQA I) Office of Product Quality Assessment I (OPQA I) Office of Pharmaceutical Quality (OPQ) | 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 2025 Playlist -    • 2025 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