Abstract
CONVOLUTION AND DECONVOLUTION BASED APPROACH FOR PREDICTION OF IN-VIVO PERFORMANCE

Nityanand Zadbuke*, A. R. Khan, Anil Battase and Sadhana Shahi

ABSTRACT

In-Vitro In-Vivo Correlation (IVIVC) is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and an in-vivo response. IVIVC play an important role in the pharmaceutical drug development as it serves as surrogate of in-vivo and assists in supporting biowaivers. The aim of present investigation is to use the outcomes of in-vitro studies of the test formulation for prediction of its in-vivo performance and to compare it with the reference to evaluate how close the agreement is? The compartment independent system approach based convolution and deconvolution procedure used for prediction of in-vivo performance. Convolution and deconvolution based prediction requires the availability of a weighting function for the human body system i.e. the unit input response (UIR). IVIVC of reference is used for the in-vivo performance prediction in terms of pharmacokinetic parameters viz. area under the curve (AUC), the maximum observed drug concentration (Cmax) and the time taken to reach the maximum concentration (Tmax). The comparison of the predicted plasma profile of test with reference show excellent agreement. A system approach based simple and practical procedure of convolution and deconvolution to predict in-vivo performance from in-vitro results is described in the present investigation.

Keywords: IVIVC, Compartment independent model, Convolution, Deconvolution, plasma concentration profile.


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