WebFeb 4, 2024 · GLSM ratios indicate a 17% increase in C max, 29% increase in AUC last, and 33% increase in AUC inf when co-administered with enzalutamide versus when taken alone. As the GLSM ratios were less than two-fold, the effect of enzalutamide on P-gp inhibition can be considered “mild.” ... WebAug 14, 2024 · The 90% CIs of the GLSM ratio of the test treatment to the reference treatment were calculated by taking the anti-log of the corresponding 90% CIs for the differences between the means on the log scale. Bioequivalence was established if the 90% CI for the ratio was within bioequivalence limits of 80.00% to 125.00% [ 23, 24 ].
Summary of Bioequivalence Studies - Clinical Review Report ...
WebMar 30, 2024 · The 90% CIs of the GLSM ratio of AUC 0–t, AUC 0–inf, and Cmax of MMF fell entirely within the 80–125% boundaries, indicating that a single oral dose of MMF 190 mg (2 × 95 mg Bafiertam™ DR capsules) is bioequivalent to DMF 240 mg (1 × 240 mg Tecfidera ® DR capsule). 3.3 Safety WebAug 14, 2024 · The GLSM ratios for rosuvastatin after repeated administration of 10 mg OCA demonstrated a modest increase in exposure of 22% for AUC ∞ and 27% for C … how do i create a linetype in autocad
Author notes - American Society of Hematology
WebMay 20, 2013 · Steady-state plasma exposure as well as steady-state peak and trough plasma exposure for USL255 were found to be equivalent to TPM-IR, as the GLSM ratio and 90% CIs of the steady-state USL255/TPM-IR AUC, C min, and C max ratios were completely contained within the 80–125% equivalence limits. WebSep 1, 2024 · Pharmacokinetic parameters were evaluated using 90% confidence intervals (CI) of the geometric least-squares mean (GLSM) ratio of the test treatment (statin coadministration with filgotinib) vs statin alone, with prespecified lack-of … WebSep 9, 2024 · Rifampin moderately reduced exposures of filgotinib and GS-829845 ( Cmax by 26% and AUC inf by 27% for filgotinib; Cmax by 19% and AUC inf by 38% for GS-829845). The data confirmed that filgotinib is a P-gp substrate. how do i create a jpeg image