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All Journal Journal of Food and Pharmaceutical Science Journal of Food and Pharmaceutical Sciences
Sekar Ayu Pawestri
Department of Pharmaceutics, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia
Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Immunology & microbiology Materials Science & Nanotechnology Medicine & Pharmacology Neuroscience

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Application in silico Modeling Simulation in Bioequivalence Studies: A Review Sekar Ayu Pawestri
Journal of Food and Pharmaceutical Sciences Vol 11, No 1 (2023): J.Food.Pharm.Sci
Publisher : Institute for Halal Industry and System (IHIS) Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/jfps.5893

Abstract

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.
Application in silico Modeling Simulation in Bioequivalence Studies: A Review Sekar Ayu Pawestri
Journal of Food and Pharmaceutical Sciences Vol 11, No 1 (2023): J.Food.Pharm.Sci
Publisher : Institute for Halal Industry and System (IHIS) Universitas Gadjah Mada

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22146/jfps.5893

Abstract

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.
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