Abstract
Establishing an in vitro–in vivo correlation (IVIVC) is based on the ability to develop an in vitro dissolution test that is predictive of the in vivo performance of the drug product. A validated IVIVC can serve as (1) a guide for the development of product, process, and meaningful specifications; (2) a reliable tool for controlling product quality; and (3) a surrogate for in vivo studies to support product and process changes. This chapter describes the basic concepts, theory, model, and evaluation methodology of IVIVC. It addresses the importance of integrating the knowledge of physicochemical and biopharmaceutical characteristics of the active pharmaceutical ingredient, dosage form, and their interplays with the gastrointestinal environment and in vitro test conditions when assessing in vitro and in vivo data during the investigation of an IVIVC. It also discusses the feasibility, opportunities, strategy, general approaches, and applications with case studies when developing IVIVC for oral dosage forms with a focus on extended-release dosage forms.
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