Bioequivalence and Bioavailability Forum

Dear all,

I would be grateful if you could provide me with some feedback regarding subject recruitment.
To prevent delays in conducting BE studies because of the difficulty in obtaining subject candidates,
Is it allowed to create 2 type of protocol and informed consent, as follows:
The first protocol (and informed concent) is made for subject recruitment of general BE studies, without specific information of investigational drugs mentioned in protocol.
Second protocol (and informed concent) is made for specific BE studies.
The main purpose of the first protocol (and informed concent) is to obtain subject pool. So when FDA approval of second protocol (and informed concent) has been obtained, we don't need to rush to get subject candidates, because we already have subject pool.

Thank you

Best regards
Joy_fm