Wagner-Nelson and Numerical Deconvolution Based Approaches for in-Vivo Performance Prediction

Khawla Rasheed

Abstract: Collected information in in-vitro dissolution studies, by means of statistical or mathematical models, can be used to predict the in-vivo performance of dosage forms, e. g. Plasma concentration of a drug. This study has a great importance in reducing the number of in-vivo human studies necessary in drug development and batch approval specification limits during drug manufacturing and as a substitute for human in-vivo studies for drug approval. In this study data from previous work for in vitro dissolution profile and in vivo plasma profile were taken and used to perform In Vitro- In Vivo correlation using tow methods, Wagner-Nelson and numerical deconvolution The results show that Wagner-Nelson has correlation coefficient between %dissolved and %absorbed of 0.85 while the numerical deconvolution shows the correlation coefficient of 0.93.

Keywords: In VitroIn Vivo Correlation, Deconvolution, Wagner-Nelson, plasma profile