Bioequivalence and Bioavailability Forum

Dear ElMaestro &Helmut,
Thank you two for your reply!Thank you so much!

❝ which is your “target” agency? If you want to submit the study to the (US)FDA you have to provide the protocol to the OGD for review anyway.

Thank you! Our target anency is not FDA but we almost follow the FDA BE GL.

I am still confused for another question. I don't know which endpoint should be chosen to specify in the protocol, AUC0-72，or instead of AUClast and AUCinf（e.g.if the half life is 18-40hr according to literature report）. As Elmaestro wrote,"...You will perhaps see some subjects do not display much of an elimination phase within the sampling time span.", while some subjects do.
Then if I choose truncated AUC0-72 instead of AUClast and AUCinf in the protocol，while most of the subjects half-life is not long enough (i.e 18hr) , actually, in this situation, it is possible the time point of 72hr sample concentration is BQL or can not be detected, then what I shoud do?
Then if I choose AUClast and AUCinf instead of AUC0-72，while most of subjects half life is very long actually, then at this situation AUCinf will be not accurately estimated.
Could I pre specify in the protocol alternatively?

Best regards!