From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus^®-Driven Framework for Generic Candesartan Cilexetil Tablets.

ABSTRACT: Background: Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first-pass metabolism, thereby introducing complexities in generic drug bioequivalence assessments. With the rapid advancement of computational technologies, the integration of biorelevant dissolution methodologies with physiologically based pharmacokinetic (PBPK) modeling is emerging as a transformative paradigm in advancing bioequivalence evaluation strategies for generic drug products. This study presents a GastroPlus^®-driven framework integrating in vivo predictive dissolution (IPD) and virtual bioequivalence (VBE) to evaluate

SUBMITTER: Ruan H 

PROVIDER: S-EPMC12030460 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature