In vitro-in vivo correlation (IVIVC): From current achievements towards the future

Abstract

Conventional in vitro-in vivo correlation (IVIVC) based on compendial dissolution testing faces many obstacles, among which are problems in establishing meaningful correlation for immediate release dosage forms, lack of intravenous data in cases of many drugs without a possibility to obtain a unit impulse response, and well-known difficulties to build an IVIVC model for BCS III and BCS IV class drugs. Three major elements are obligatory for IVIVC development: in vitro dissolution data, in vivo pharmacokinetic profile, and modeling tools. Dissolution testing and modeling approaches are under heavy development to create predictive IVIVIC/IVIVR models. Application of noncompendial dissolution methods, biorelevant media, and equipment simulating the human gastrointestinal tract, together with sophisticated multivariate statistical methods and mechanistic approaches, are nominated to be the future of IVIVC.