چکیده مقاله
This study presents a comprehensive bioequivalence analysis of regorafenib in human plasma using a validated LC MS/MS method Regorafenib, a multi kinase inhibitor, was analyzed in plasma samples collected from volunteers administered both test and reference formulations The analytical method employed included the use of sorafenib as an internal standard, ensuring accuracy and precision Validation parameters, such as specificity, linearity, precision, and accuracy, were evaluated in accordance with the ICH M11 and EMEA guidelines The method demonstrated robust performance with calibration curves showing linearity in the range of 1 5–41 ppb and acceptable precision, with %RSD values below 11 Bioequivalence studies were conducted on 25 healthy volunteers under a crossover design Plasma concentrations of regorafenib were quantified at multiple time points, enabling the calculation of pharmacokinetic parameters, including Cmax, Tmax, and AUC Results indicated that the test and reference formulations were bioequivalent, with geometric mean ratios falling within the acceptable range of 0 1–1 25 The developed LC MS/MS method, characterized by its high sensitivity and selectivity, proved effective for routine bioequivalence studies of regorafenib This research highlights the importance of rigorous validation and methodological precision in bioequivalence studies, ensuring reliability in drug evaluation and regulatory compliance
کلیدواژهها
نویسندگان
Dariush Omidfar
Payesh Darou Zist Azma Company, East Azerbaijan, Tabriz, Iran
Ahad Sheikhloo
Payesh Darou Zist Azma Company, East Azerbaijan, Tabriz, Iran
شیوه ارجاع
Omidfar, Dariush and Sheikhloo, Ahad,1403,Bioequivalence Analysis of Regorafenib in Human Plasma Using LC -MS/MS: Validation and Application,Third International Conference for Iranian Hygienics and Health Sciences Students,Tehran
ارائهشده در
مجموعه مقالات سومین کنفرانس بین المللی دانشجویان بهداشت و علوم سلامت ایران30 بهمن 1403 · تهران