Abstract: The in vitro-in vivo correlation (IVIVC) model is often established for the oral solid extended release drug product development in order to predict accurately and precisely the expected bioavailability characteristics for the product from dissolution profile characteristics study.In the past several years, CDE occasionally received IVIVC documents for applying waiver of in vivo bioequivalence study when it is necessary to document bioequivalence because of post-approval changes (e.g., formulation, strength, manufacturing site changes, etc.).This paper discussed the key points in the IVIVC development program and introduced the considerations from CDE perspective in reviewing these applications.

Key words: in vitro-in vivo correlation, drug evaluation