Abstract

IN VIVO – IN VITRO CORRELATION – A STRATEGIC TOOL FOR DRUG DEVELOPMENT

Sunisha Kulkarni*, Apoorva Rathod, Preeti Sharma and Priyanka Keshri

ABSTRACT

Development and optimization of formulation is an integral part of manufacturing and marketing of any therapeutic agent, which is a time consuming and costly process. Correlation between In Vivo – In Vitro (IVIV) data is often used after proper validation. It predicts the bioavailability results from in vitro dissolution. In this paper, we have described an in vitro advanced gastric model to study the behavior of oral compounds under interactive kinetic conditions in the human stomach. This model simulates the motility and pressure forces in the different regions of stomach, the rate and composition of gastric secretion fluid. IVIVC is a mathematical model, among all the three levels of correlation Level A is widely accepted by regulatory agencies.

Keywords: In Vivo – In Vitro Correlation, validation, bioavailability, advanced gastric model, etc.