Bioequivalence and Bioavailability Forum

Hello Mittyri,

thank you for the answer and the literature provided!

❝ They used prespecified no-effect boundaries of 70–143%, but for rosuvastatin the point estimate came out.

Phew, interestingly the PE was not even that close to these boundaries, basically the whole 90% confidence interval for Cmax was outside:"Rosuvastatin exposure was moderately higher with filgotinib coadministration—GLSM ratios (90% CI), 1.68 (1.43‐1.97) for Cmax; 1.42 (1.30‐1.57) for AUCinf—but this was not considered clinically relevant."

❝ So it’s not the pure PE only unicorn you’re looking for, but it’s a regulatory-accepted situation where the boundary was obviously wider than 80–125%, the PEs slightly breached the prespecified limit, and the agency still said “no issue” purely because of the solid PK/PD reasoning.

Thanks, as expected PK/PD justification has to be provided

Regards
BEQool