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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
Aims Senaparib (Sepalna®), a novel oral poly (adenosine diphosphate -ribose) polymerase (PARP) 1/2 inhibitor, was approved in China in 2025 as maintenance therapy for advanced ovarian cancer. The recommended starting dose is 100 mg once daily, which may be adjusted to 80 mg, 60 mg, or 40 mg to manage adverse events. Wh...
Development and validation of an HPLC-MS/MS method for the quantification of Aficamten in human plasma and urine and application to a clinical pharmacokinetic study.
An innovative, rapid, and highly sensitive HPLC-MS/MS approach for quantifying aficamten concentrations in human plasma and urine is established and critical validation parameters including matrix effects, extraction recovery, carryover, and stability were assessed.