FDA discusses additional topics in complex generic topical products. Includes responses to audience in a question-and-answer panel. Presenters and presentations include:

Common Issues Identified in In-vitro Release Test (IVRT) and In-vitro Permeation Test (IVPT) Studies Submitted in ANDA to Support Bioequivalence for Topical Products
Josephine Aimiuwu, PhD; DB II|OB|OGD|CDER

Theoretical Principles and Best Practices: In Vitro Release Test
Tannaz Ramezanli, PhD, PharmD; DTP I|ORS|OGD|CDER

Theoretical Principles and Best Practices: In Vitro Permeation Test
Priyanka Ghosh, PhD; DTP I|ORS|OGD|CDER

Q&A Panel (Including all above presenters):
Markham Luke, MD, PhD; DTP I|ORS|OGD|CDER
Sam Raney, PhD; IO|ORS|OGD|CDER
For slides and additional information: [ Ссылка ]
-------------------- 
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 - [ Ссылка ]
SBIA Listserv - [ Ссылка ]
SBIA 2021 Playlist - [ Ссылка ]
SBIA LinkedIn - [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367

свернуть