Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and  Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation

CONCLUSIONS: The RS-DAT met BE criteria (range 80%-125%) versus SAC based on 90% CI of GMR for Cmax,ss and AUC 0-24h,ss. The LS-DAT was considered BE to SAC on the basis of the niraparib component meeting the BE criteria in the primary analysis for AUC 0-72h; abiraterone meeting the BE criteria in additional paired analyses based on Cmax,ss and AUC 0-24h,ss; and the percentage of simulated LS-DAT versus SAC BE trials meeting the BE criteria for both.GOV IDENTIFIER: NCT04577833.PMID:38436924 | DOI:10.1007/s40262-023-01340-5

Source: Clinical Prostate Cancer - March 4, 2024 Category: Cancer & Oncology Authors: Alex Yu Anasuya Hazra James Juhui Jiao Peter Hellemans Anna Mitselos Hui Tian Juan Jose Perez Ruixo Nahor Haddish-Berhane Daniele Ouellet Alberto Russu Source Type: research