Bioequivalence and Bioavailability Forum

❝ For subjects where C_max occurs at the first post-dose sampling time, the actual C_max may have been missed as it could have occurred at an earlier time point. When this occurs, the robustness of the study results in relation to the potential missed C_max should be discussed. This could include additional analysis where data from the affected subjects are removed from the analysis.

❝ In other words, it is the other way around than for the FDA. Keep the subject(s) in the primary analysis and exclude them in a sensitivity analysis.