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Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations

In vivo pharmacokinetic simulations and virtual bioequivalence (BE) evaluation of cilostazol have not yet been described for humans. Here, we successfully developed a physiologically based absorption model to simulate plasma concentrations of cilostazol. In addition, virtual population simulations i...

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Detalles Bibliográficos
Autores principales: Wang, Lu, Zhao, Pengfei, Luo, Ting, Yang, Dandan, Jiang, Qianqian, Chen, Jinliang, Lou, Honggang, Ruan, Zourong, Jiang, Bo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10651633/
https://www.ncbi.nlm.nih.gov/pubmed/37718502
http://dx.doi.org/10.1111/cts.13633
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author Wang, Lu
Zhao, Pengfei
Luo, Ting
Yang, Dandan
Jiang, Qianqian
Chen, Jinliang
Lou, Honggang
Ruan, Zourong
Jiang, Bo
author_facet Wang, Lu
Zhao, Pengfei
Luo, Ting
Yang, Dandan
Jiang, Qianqian
Chen, Jinliang
Lou, Honggang
Ruan, Zourong
Jiang, Bo
author_sort Wang, Lu
collection PubMed
description In vivo pharmacokinetic simulations and virtual bioequivalence (BE) evaluation of cilostazol have not yet been described for humans. Here, we successfully developed a physiologically based absorption model to simulate plasma concentrations of cilostazol. In addition, virtual population simulations integrating dissolution of 0.3% sodium dodecyl sulfate water media were executed to evaluate the BE of test and reference formulations. Simulation results show that test and reference formulations were bioequivalent among 28 subjects, but not nine subjects, consistent with clinical studies. The model proved to be an important tool to show potential BE for cilostazol. This finding may facilitate understanding of the potential risks during the development of generic products.
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spelling pubmed-106516332023-09-25 Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations Wang, Lu Zhao, Pengfei Luo, Ting Yang, Dandan Jiang, Qianqian Chen, Jinliang Lou, Honggang Ruan, Zourong Jiang, Bo Clin Transl Sci Research In vivo pharmacokinetic simulations and virtual bioequivalence (BE) evaluation of cilostazol have not yet been described for humans. Here, we successfully developed a physiologically based absorption model to simulate plasma concentrations of cilostazol. In addition, virtual population simulations integrating dissolution of 0.3% sodium dodecyl sulfate water media were executed to evaluate the BE of test and reference formulations. Simulation results show that test and reference formulations were bioequivalent among 28 subjects, but not nine subjects, consistent with clinical studies. The model proved to be an important tool to show potential BE for cilostazol. This finding may facilitate understanding of the potential risks during the development of generic products. John Wiley and Sons Inc. 2023-09-25 /pmc/articles/PMC10651633/ /pubmed/37718502 http://dx.doi.org/10.1111/cts.13633 Text en © 2023 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Research
Wang, Lu
Zhao, Pengfei
Luo, Ting
Yang, Dandan
Jiang, Qianqian
Chen, Jinliang
Lou, Honggang
Ruan, Zourong
Jiang, Bo
Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations
title Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations
title_full Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations
title_fullStr Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations
title_full_unstemmed Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations
title_short Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations
title_sort physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10651633/
https://www.ncbi.nlm.nih.gov/pubmed/37718502
http://dx.doi.org/10.1111/cts.13633
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