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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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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. |
format | Online Article Text |
id | pubmed-10651633 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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