Tricky… [RSABE / ABEL]

posted by wienui  – Germany, Oman, 2020-01-30 18:53  – Posting: # 21111
Views: 4,414

(edited by wienui on 2020-01-30 19:04)

Hello Helmut,

» For the Gulf Cooperation Council (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates) and South Africa you can use ABE for Cmax with fixed (!) limits of 75.00–133.33% if CVwR <30%.

I think there is a mistake here, you are right according to the fixed limit of 75-133% in the GCC Guidelines in the case of HVD (HVDP) which is absolutely not correct and cause a lot of problems in the evaluation of such drug formulation's types, BUT widen to this range is not in the case of ABE and not at all if CVwR <30% .

As according to GCC GL (citation down) a replicate design and prove of CVwR >30% ( not<) is required to wide only the Cmax.


"Those HVDP for which a wider difference in Cmax is considered clinically irrelevant based on a sound clinical justification can be assessed with a widened acceptance range. If this is the case, a wider acceptance range (i.e. 75-133%) for Cmax can be used. For the acceptance interval to be widened the bioequivalence study must be of a replicate design where it has been demonstrated that the within subject variability for Cmax of the reference compound in the study is >30%."
Best regards,

Osama

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