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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-human-drugs/advancing-generic-drug-development-translating-science-approval-09212021-09222021
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