Data for: In silico prediction of bioequivalence of Isosorbide Mononitrate tablets with different dissolution profiles using PBPK modeling and simulation

Published: 26 October 2020| Version 1 | DOI: 10.17632/s5nb3bxyjf.1
Contributor:
zhang fan

Description

The research data files are compromise of 5 supplementary materials. The detailed information of clinical study is displayed in Supplementary material 1, and all simulated data in manuscript are shown in supplementary material 2-5: 1) supplementary material 1 (the detailed information of clinical study) 2) supplementary material 2 (the simulated data used for internal verification of PBPK model) 3) supplementary material 3 (the simulated data used for external verification of PBPK model) 4) supplementary material 4 (the simulated data used in the section 4.3 of manuscript) : this simulated data was used to explore whether the rapid dissolution rate (dissolved ≥ 85% in 30 min) are necessary to ensure the bioequivalence for BCS I class drug 5) supplementary material 5 (the simulated data used in the section 4.4 of manuscript) : this simulated data was used to establish a clinically relevant dissolution specification of Isosorbide Mononitrate tablets.

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Pharmacokinetics, Pharmacokinetic Modeling, Bioequivalence

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