Abstract

THE COMPARITIVE STUDY OF IVIVC CORRELATION AND ITS INTERPRETATION

Bogadi Subhasri, Prof. K. Thyagaraju and Vothini Sarath Babu*

ABSTRACT

The in vitro- in vivo correlation is important for development of dosage form. In vitro dissolution studies are not sufficient for explain therapeutic activity of drug. So IVIVC is one of mathematical model which is used to explain a relation between in vitro dissolution and in vivo bioavailability. In vitro dissolution means process of release of drug from dosage form which reflect a bioavailability where as in vivo, release of drug from gastrointestinal tract must reflect the profile of dosage form in order to assure a biological response. The main purpose of studying IVIVC is product development and surrogate for in vivo studies to support biowaivers also allow the setting dissolution specification and methods. The pharmaceutical industries are in search of way that can save a cost and resources of drug development. The IVIVC fixes dissolution acceptance criteria and also used in bioequivalence study. The different levels of IVIVC was proposed for oral dosage forms and later adopted globally. Currently the four levels are categorised by FDA depending upon type of data used to establish relationship and predict the complete plasma profile of dosage form.

Keywords: IVIVC correlation, dissolution, Interpretation.