Lead Pharmacologist U.S. Food and Drug Administration Silver Spring, Maryland
This presentation will provide an overview for scientific and regulatory considerations on developing generic poly(lactide-co-glycolide) (PLGA) based drug products. Discussions will be made on 1) the scope of pharmaceutical equivalence and bioequivalence of these products; 2) characterization of PLGA polymers for establishing formulation qualitative sameness; 3) formulation characterization for supporting product development; and 4) in vitro and in vivo studies for bioequivalence purpose.
Two to three case studies will be presented to highlight: 1) common deficiencies for comparative polymer characterization; 2) roles and expectations for comparative formulation characterization; and 3) remaining scientific and regulatory challenges for generic development.
The presentation will also provide a brief overview of the GDUFA funded research activities in the area of PLGA based drug products.
Learning Objectives:
Upon completion, participants will be able to better understand the scope of pharmaceutical equivalence and bioequivalence of PLGA based long acting injectable products.
Upon completion, participants will be able to describe the purpose of comparative polymer characterization.
Upon completion, participants will be able to discuss the progress in reserach activities on PLGA based drug products
Upon completion, participants will be able to have a good understanding which may enable them to explore potential novel approaches for supporting bioequivalence of PLGA based drug products.
Unpon completion, participants will be able to understand the possible regulatory pathways for effective communication with the FDA during product development.