Senior Staff Fellow U.S. FDA Silver Spring, Maryland
This presentation will provide an overview of advances in in vitro equivalence testing for long-acting injectable (LAI) products. This presentation will discuss (1) overview of different types of LAI products (2) the scope of in vitro equivalence testing for different LAI products (why/when is needed); (3) considerations on establishing in vitro equivalence of LAI products; (3) advances in physicochemical characterization and in vitro drug release testing tools for in vitro equivalence testing.
Learning Objectives:
Upon completion, the participate will be able to gain understanding of the unique scientific and regulatory considerations involved in the development and approval of LAI products.
Upon completion, the participant will be able to gain understanding on new tools to characterize LAI drug products.
Upon completion, the participant will be able to gain understanding on how formulation and manufacturing process can impact the physicochemical and pharmacokinetic properties of LAI products.