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

The virtual BE simulation of Isosorbide Mononitrate tablets with different dissolution profiles was performed by using PBPK modeling. It was proved that the rapid dissolution rate (≥85% in 30 min)wasnotnecessary to guarantee bioequivalence for BCS class Idrug and a clinically relevant dissolution specificationwas furtherestablished for screening the BE and non-BE batches.Image, graphical abstract