An In Silico Approach toward the Appropriate Absorption Rate Metric in Bioequivalence.

ABSTRACT: In bioequivalence, the maximum plasma concentration (Cmax) is traditionally used as a metric for the absorption rate, despite the fact that there are several concerns. The idea of "average slope" (AS) was recently introduced as an alternative metric to reflect absorption rate. This study aims to further extend the previous findings and apply an in silico approach to investigate the kinetic sensitivity of AS and Cmax. This computational analysis was applied to the C-t data of hydrochlorothiazide, donepezil, and amlodipine, which exhibit different absorption kinetics. Principal component analysis (PCA) was applied to uncover the relationships between all bioequivalence metrics. Monte Carlo simulations of bioequivalence trials were performed to investigate sensitivity. The appropriate program

SUBMITTER: Karalis VD 

PROVIDER: S-EPMC10221334 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature