Helmut
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2023-06-23 10:55
(356 d 00:35 ago)

Posting: # 23611
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 SFDA BE GL v3.1 (also GCC?) [Regulatives / Guidelines]

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?


  • Schütz H, Labes D, Wolfsegger MJ. Critical Remarks on Reference-Scaled Average Bioequivalence. J Pharm Pharmaceut Sci. 25: 285–96. [image] doi:10.18433/jpps32892.

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khaledazeid
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2023-07-01 20:09
(347 d 15:21 ago)

@ Helmut
Posting: # 23643
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 SFDA BE GL v3.1 (also GCC?)

Dear Helmut,
Yes it is implemented for all GCC members
Helmut
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2023-07-01 23:54
(347 d 11:37 ago)

@ khaledazeid
Posting: # 23644
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 SFDA BE GL v3.1 (GCC reference?)

Salam khaledazeid,

❝ Yes it is implemented for all GCC members


THX for the clarification! Do you have a reference? We want to release new versions of PowerTOST and replicateBE soon.

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wienui
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Germany/Oman,
2023-07-04 19:35
(344 d 15:55 ago)

(edited by on 2023-07-04 19:58)
@ Helmut
Posting: # 23651
Views: 1,450
 

 SFDA BE GL v3.1 (also GCC?)

❝ 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.

Cheers,
Osama
Helmut
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2023-07-04 21:46
(344 d 13:45 ago)

@ wienui
Posting: # 23652
Views: 1,363
 

 SFDA BE GL v3.1 (also GCC)

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. :thumb up:

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