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The permeability of the test product was evaluated by the formation of a single membrane with Caco-2, which was used to support the prediction of oral bioavailability and BCS classification, and to provide reference for supporting some clinical trial exemptions.
Incubation system | Cells: Caco-2 cells |
Test concentrations | 1 to 3 samples were designed based on known efficacy and toxicity data |
Cell density | 0.8×108 cells/well |
Culture time | At 21 days, they differentiated into monolayer dense cells |
Incubation time | 2 h |
Analytical method | LC-MS/MS or microcoder |
Data presentation | Apparent permeability coefficient（Papp） Efflux ratio (ER) |