Bioequivalence and Bioavailability Forum

❝ Dear all – and especially my dearest friend Osama!

My dear friend Helmut,
Sorry for not responding early, due to personal and health conditions.

❝ Now for the question: 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.


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.