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References from 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. Local targets link to admitted publications; unresolved targets remain external evidence.
Advancements in virtual bioequivalence: a systematic reviewof computational methods and regulatory perspectives in the pharmaceutical industry
10.3390/pharmaceutics16111414 · 2024 · External reference
Proof of concept in assignment of within-subject variability during virtual bioequivalence studies: propagation of intra-subject variation in gastrointestinal physiology using physiologically based pharmacokinetic modeling
10.1208/s12248-021-00672-z · 2022 · External reference
Discovery and development of PARP inhibitor senaparib
10.1158/1538-7445.am2022-1399 · 2022 · External reference
The discovery of a potent PARP1 inhibitor senaparib
10.1158/1535-7163.mct-23-0625 · 2025 · External reference
Safety, tolerability, and pharmacokinetics of senaparib, a novel PARP1/2 inhibitor, in Chinese patients with advanced solid tumors: a phase I trial
10.1093/oncolo/oyad163 · 2023 · External reference
Unresolved reference
2020 · External reference
A phase 1 dose-escalation study of the poly (ADP-ribose) polymerase inhibitor senaparib in Australian patients with advanced solid tumors
10.1002/cncr.34662 · 2023 · External reference
Dissolution and translational modeling strategies toward establishing an in vitro-in vivo link-a workshop summary report
10.1208/s12248-019-0298-x · 2019 · External reference
Effect of a strong CYP3A4 inhibitor and inducer on the pharmacokinetics of senaparib (IMP4297) in healthy volunteers: a drug-drug interaction study
10.1111/bcp.15624 · 2023 · External reference
Unresolved reference
2025 · External reference
Modelling based approaches to support generic drug regulatory submissions-practical considerations and case studies
10.1208/s12248-023-00831-4 · 2023 · External reference
Advancing virtual bioequivalence for orally administered drug products: methodology, real-world applications and future outlook
10.3390/ph17070876 · 2024 · External reference
Deconvolution and IVIVC: exploring the role of rate-limiting conditions
10.1208/s12248-015-9849-y · 2016 · External reference
Virtual bioequivalence assessment of elagolix formulations using physiologically based pharmacokinetic modeling
10.1208/s12248-023-00794-6 · 2023 · External reference
Unresolved reference
2025 · External reference
Applications of clinically relevant dissolution testing: workshop summary report
10.1208/s12248-018-0252-3 · 2018 · External reference
Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial
10.1038/s41591-024-03003-9 · 2024 · External reference
In silico prediction of bioequivalence of isosorbide mononitrate tablets with different dissolution profiles using PBPK modeling and simulation
10.1016/j.ejps.2020.105618 · 2021 · External reference
Predicting the pharmacokinetics of orally administered drugs across BCS classes 1-4 by virtual bioequivalence model
10.1021/acs.molpharmaceut.2c00688 · 2023 · External reference
