Cutting Edge Science in Complex Generics скачать в хорошем качестве

Cutting Edge Science in Complex Generics

FDA discusses topics in cutting edge science in complex generics. Includes responses to audience in a question-and-answer panel. Presenters and presentations include: Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs Meng Hu, PhD; DQMM|ORS|OGD|CDER Model-Integrated Evidence for Bioequivalence Assessment of Complex Generic Drugs Miyoung Yoon, PhD; DQMM|ORS|OGD|CDER Scanning Electron Cryomicroscopy (Cryosem) for Characterization of Complex Drug Products Huzeyfe Yilmaz, PhD; DCDA|OTR|OGD|CDER Advanced Imaging and Data Analysis to Support Compositional Structure Similarity of Polymeric Formulations Yan Wang, PhD; DTP I|ORS|OGD|CDER Q&A Panel (Including all above presenters): Robert Lionberger, PhD; ORS|OGD|CDER Daniel Willet, PhD; DCDA|OTR|OGD|CDER For slides and additional information: 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 - [email protected] Phone - (301) 796-6707 I (866) 405-5367