ABSTRACT
The recent advances in dissolution methodologies coupled with the availability of sophisticated modeling software enabled dissolution testing to be used more and more both by the industry and regulatory agencies, as a predictor of differences in bioavailability. This chapter gives an overview for the various requirements from a regulatory perspective for establishing, validating, and applying an in vitro–in vivo correlation (IVIVC). It presents case studies on how a predictive IVIVC could be used from both a regulatory and industrial perspective to obtain in vivo bioavailability waivers, as well as setting meaningful dissolution specifications. The chapter encompasses case studies on both conventional modified release (MR) dosage forms and specialized dosage forms such as implantables and vaginal rings. It discusses issues relating to the elution of drug-eluting stents (DES). Once an IVIVC has been established, a crucial determination of its applicability is its ability to predict the plasma concentration time profile accurately and consistently.
