Application in silico Modeling Simulation in Bioequivalence Studies: A Review
Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies. Various computer simulation software is used to gen...
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| Format: | Article |
| Language: | English |
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LPPT Universitas Gadjah Mada
2023-03-01
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| Series: | Journal of Food and Pharmaceutical Sciences |
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| Online Access: | https://jurnal.ugm.ac.id/v3/JFPS/article/view/5893 |
| _version_ | 1797448430924070912 |
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| author | Sekar Ayu Pawestri |
| author_facet | Sekar Ayu Pawestri |
| author_sort | Sekar Ayu Pawestri |
| collection | DOAJ |
| description | Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies. Various computer simulation software is used to generate the simulation and model input data. This review summarizes the software used for predicting in vivo performance which supports the analysis of virtual bioequivalence testing. GastroPlus™ and SimCyp® are widely used platforms in generating data for virtual bioequivalence studies. The studies suggest that the validity procedure is necessary for modeling and simulation. The in silico method has become a valuable tool in bioequivalence studies as supporting extension of the biowaiver drug list and contributing to future drug development. |
| first_indexed | 2024-03-09T14:10:20Z |
| format | Article |
| id | doaj.art-ddb41a3990f3465a98cbc70cc121f21b |
| institution | Directory Open Access Journal |
| issn | 2089-7200 2339-0948 |
| language | English |
| last_indexed | 2024-03-09T14:10:20Z |
| publishDate | 2023-03-01 |
| publisher | LPPT Universitas Gadjah Mada |
| record_format | Article |
| series | Journal of Food and Pharmaceutical Sciences |
| spelling | doaj.art-ddb41a3990f3465a98cbc70cc121f21b2023-11-29T13:54:07ZengLPPT Universitas Gadjah MadaJournal of Food and Pharmaceutical Sciences2089-72002339-09482023-03-0176376910.22146/jfps.58935893Application in silico Modeling Simulation in Bioequivalence Studies: A ReviewSekar Ayu Pawestri0Department of Pharmaceutics, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta, IndonesiaBioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies. Various computer simulation software is used to generate the simulation and model input data. This review summarizes the software used for predicting in vivo performance which supports the analysis of virtual bioequivalence testing. GastroPlus™ and SimCyp® are widely used platforms in generating data for virtual bioequivalence studies. The studies suggest that the validity procedure is necessary for modeling and simulation. The in silico method has become a valuable tool in bioequivalence studies as supporting extension of the biowaiver drug list and contributing to future drug development.https://jurnal.ugm.ac.id/v3/JFPS/article/view/5893modelingsimulationbioequivalencebiowaiverin silico |
| spellingShingle | Sekar Ayu Pawestri Application in silico Modeling Simulation in Bioequivalence Studies: A Review Journal of Food and Pharmaceutical Sciences modeling simulation bioequivalence biowaiver in silico |
| title | Application in silico Modeling Simulation in Bioequivalence Studies: A Review |
| title_full | Application in silico Modeling Simulation in Bioequivalence Studies: A Review |
| title_fullStr | Application in silico Modeling Simulation in Bioequivalence Studies: A Review |
| title_full_unstemmed | Application in silico Modeling Simulation in Bioequivalence Studies: A Review |
| title_short | Application in silico Modeling Simulation in Bioequivalence Studies: A Review |
| title_sort | application in silico modeling simulation in bioequivalence studies a review |
| topic | modeling simulation bioequivalence biowaiver in silico |
| url | https://jurnal.ugm.ac.id/v3/JFPS/article/view/5893 |
| work_keys_str_mv | AT sekarayupawestri applicationinsilicomodelingsimulationinbioequivalencestudiesareview |