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Abstract

In Vitro In Vivo Correlation Of Oral Drug Formulations : An Overview

Author(s): C. J Shishoo, S. S Savale, S. A Shah, I. S Rathod

Dissolution test is an important quality control tool, provided it is based on a meaningful in vitro in vivo correlation (IVIVC). Such dissolution test can prove as a surrogate to the extensive, expensive and time consuming in vivo bioavailability testing on humans. This review discusses what are the IVIVCs and different levels of IVIVCs, and encompasses various approaches to seek meaningful IVIVCs, mainly for oral solid dosage forms. Discussed are different modifications in in vitro dissolution testing to simulate the in vivo environment, to which the formulation is subjected to after oral administration. IVIVCs with high quality and predictability can substantiate such in vitro dissolution tests, espqcially, to guide development of new modified release formulations of drugs with narrow therapeutic window. It also assesses the lot-to-lot quality of the drug product to ensure product safety and efficacy.