Absorption Systems

https://www.pharmtech.com/pt_w/ophthalmics

Understand the regulatory framework for generic ophthalmic drug products

Hear about recent pharmacokinetic and pharmacodynamic studies to better understand the 

 impact of differences in product formulation

Learn about recent advances in the development of ocular physiological-based pharmacokinetic (PBPK) modeling and simulation


Deputy Division Director
US Food and Drug Administration, Office of Generic Drugs


Dr. Darby Kozak is the Deputy Division Director for the Division of Therapeutic Performance One (DTP1), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). In this role, he leads a group of interdisciplinary scientists and oversees research projects on the development of new analytical methods and equivalence evaluation methodologies for complex drug products and formulations. He specializes in complex drug substances, products that incorporate nanotechnology, and complex parenteral, ophthalmic, and otic formulations. Prior to joining the FDA in 2015, Dr. Kozak was the chief scientist for Izon Science, a research fellow at the Australian Institute for Bioengineering and Nanotechnology, and visiting fellow at the Fred Hutchinson Cancer Research Center. Dr. Kozak has a bachelor’s degree in chemical engineering from the University of Washington (Seattle, WA) and a doctorate in chemistry from the University of Bristol (United Kingdom).

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Thursday, August 5, 2021 at 11am EDT| 8am PDT| 4pm BST|5pm CEST



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