Related Experiment Video
Updated: Nov 19, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
An In Vitro-In Vivo Simulation Approach for the Prediction of Bioequivalence
Marilena Vlachou1, Vangelis Karalis1
1Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, 15784 Athens, Greece.
Abstract:
The aim of this study was to develop a new in vitro-in vivo simulation (IVIVS) approach in order to predict the outcome of a bioequivalence study. The predictability of the IVIVS procedure was evaluated through its application in the development process of a new generic product of amlodipine/irbesartan/hydrochlorothiazide. The developed IVIVS methodology is composed of three parts: (a) mathematical description of in vitro dissolution profiles, (b) mathematical description of in vivo kinetics, and (c) development of joint in vitro-in vivo simulations. The entire programming was done in MATLAB® and all created scripts were validated through other software. The IVIVS approach can be implemented for any number of subjects, clinical design, variability and can be repeated for thousands of times using Monte Carlo techniques. The probability of success of each scenario is recorded and finally, an overall assessment is made in order to select the most suitable batch. Alternatively, if the IVIVS shows reduced probability of BE success, the R&D department is advised to reformulate the product. In this study, the IVIVS approach predicted successfully the BE outcome of the three drugs. During the development of generics, the IVIVS approach can save time and expenses.
More Related Videos
13:34A Combined 3D Tissue Engineered In Vitro/In Silico Lung Tumor Model for Predicting Drug Effectiveness in Specific Mutational Backgrounds
Published on: April 6, 2016
07:09Use of a High-throughput In Vitro Microfluidic System to Develop Oral Multi-species Biofilms
Published on: December 1, 2014
Related Concept Videos
Equivalence: In Vitro and In Vivo Bioequivalence
Bioequivalence studies: Biowaivers
Drug Product Performance: In Vitro–In Vivo Correlation
Bioequivalence: Overview
Bioequivalence of Drugs: Drugs with Multiple Indications
Bioequivalence Data: Statistical Interpretation