Bioequivalence and Bioavailability Forum

Dear all,

❝ If I understand well the idea is only to test for futility. This is unusual in BE trials, but common practice in Phase III trials. The futility test should be described in the protocol submitted to the Ethics Committee.

Correct. Since to my knowledge nothing is published yet, perform simulations before the study in order to demonstrate that the patient’s risk (type I error) is maintained. Hint: The -package Power2Stage.

❝ What I think would not be acceptable to Agencies (at least in Europe)…

Correct again. BE-GL, Subject accountability:

The data from all treated subjects should be treated equally. […] It should be planned that all treated subjects should be included in the analysis […].