Bioequivalence and Bioavailability Forum

Salam Osama!

❝ Sorry for not responding early, due to personal and health conditions.

I hope everything is resolved in the meantime!

❝ ❝ […] Is this guideline implemented only in Saudi Arabia or in all members of the Gulf Cooperation Council as well?

❝ Yes, as Clarified by khaledazeid, it is applied in all GCC member states. Unfortunately, there is no reference, that we could refer to, But it is totally sure that all GCC members are applying this GL.

Thank you so much. We will update PowerTOST and replicateBE accordingly (while keeping the previous approach for historical reasons).

❝ By the way, Regarding to the inflation of Type I Error for HVD(P)'s especially if the estimated CVwR >40%, lower limit <75%, upper limit >133%, it was called several times for the amendment of this point in the GCC GL since 2016 and as a result, there were clear instructions that the assessor has to follow the EMA in this matter but officially it still there in the GL.

Very good, will not give me headaches any longer.