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An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence

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/irbesar...

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Autores principales: Vlachou, Marilena, Karalis, Vangelis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7865526/
https://www.ncbi.nlm.nih.gov/pubmed/33498960
http://dx.doi.org/10.3390/ma14030555
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author Vlachou, Marilena
Karalis, Vangelis
author_facet Vlachou, Marilena
Karalis, Vangelis
author_sort Vlachou, Marilena
collection PubMed
description 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.
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spelling pubmed-78655262021-02-07 An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence Vlachou, Marilena Karalis, Vangelis Materials (Basel) Article 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. MDPI 2021-01-24 /pmc/articles/PMC7865526/ /pubmed/33498960 http://dx.doi.org/10.3390/ma14030555 Text en © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Vlachou, Marilena
Karalis, Vangelis
An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence
title An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence
title_full An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence
title_fullStr An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence
title_full_unstemmed An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence
title_short An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence
title_sort in vitro–in vivo simulation approach for the prediction of bioequivalence
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7865526/
https://www.ncbi.nlm.nih.gov/pubmed/33498960
http://dx.doi.org/10.3390/ma14030555
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