Bioequivalence and Bioavailability Forum

❝ Dear colleagues, we are conducting a pivotal fed-fasted BE study versus a reference listed drug (RLD).

Here is my opinion:

Essentially it is your study and you have to defend the submission, it is your prerogative to have what you want. - CRO gets most of their money when they deliver draft report (study pass/fail)

If it is a complex study - you have to predefine critical steps in the SAP (before the sample analysis start- to avoid any claims of Bias).

If it is a study against the product specific guidance and logical analysis is easy to understand you can refer to the FDA guidance(s) in the protocol.