SFDA BE GL v3.1 (also GCC?) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2023-06-23 10:55 (331 d 02:54 ago) – Posting: # 23611
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Dear all – and especially my dearest friend Osama!

Direct fixed BE-limits of 75.00–133.33% for Cmax of HVD(P)s (if the estimated \(\small{CV_\text{wR}>30\%}\)) were recommended by the Gulf Cooperation Council’s guideline v2.4 of May 2011 and in all later versions up to v3.0 of May 2021. This may lead to an inflation of the Type I Error if the true \(\small{CV_\text{wR}\leq30\%}\) (see this article).

Section 3.1.10 was changed in the current v3.1 of 10 August 2022 to the EMA’s Average Bioequivalence with Expanding Limits (ABEL). An important step towards global harmonization. That’s much better if the estimated \(\small{CV_\text{wR}\leq30\%}\) but worse if the estimated \(\small{CV_\text{wR}>30\%}\). Given, since the inflation of the Type I Error if the true \(\small{CV_\text{wR}\leq30\%}\) in the previous approach was massive.*

Now for the question: Is this guideline implemented only in Saudi Arabia or in all members of the Gulf Cooperation Council as well?

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Helmut Schütz

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