SEP 4, 2026 · JOURNAL ARTICLE
A PBPK-VBE approach for bioequivalence extrapolation of senaparib capsule strengths in the context of nonlinear pharmacokinetics: bridging from the clinical starting dose to the linear pharmacokinetic range
Frontiers in Pharmacology
A sound methodological approach (PBPK-VBE modeling) applied to a regulatory question, but based on simulation and in vitro data without in vivo clinical confirmation across the lower dose range, making it supportive rather than definitive evidence.
Reported
Geometric mean ratios (GMRs) for…consistently approached 100%