Bioequivalence and Bioavailability Forum

❝ Dear all,

❝ Thanks in advance

Dear Mikalai, Bonferroni correction performed when two o more independent tests done. And this correction is very rude (More delicate is Sidak correction). But in case of adaptive design we have one test, and then another with part of same data. We don't have independent comparation and we should spend our alpha: one part in first test, another at second. And we can spend any proportion of alpha as we wish, but overal alpha should not be greater, for example 0.05. We should use an application of alpha-spending function. Pocock boundary, Haybittle–Peto boundary, O'Brien–Fleming boundary - there are many approaches to work with interim analysis.

Range of CI itself don't influence on TIE, it is only convention. But when CI dynamically changing I think there is no good definition for TIE. For fixed CI TIE means that real GMR may be outside permissible range with this chance. Very touching assumption to consider that TIE for RSABE is a chance when GMR outside 0.8-1.25 and with this comprehension make CI range wider. Really in this situation TIE not the same as in fixed case. But people want to make ABE for high-variable drug and try to do this it's like attempt to trick statistics...

But I could be wrong...