Tricky… [RSABE / ABEL]

posted by wienui  – Germany/Oman, 2020-01-30 19:53 (1096 d 11:22 ago) – Posting: # 21111
Views: 18,345

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,


Complete thread:

UA Flag
 Admin contact
22,477 posts in 4,708 threads, 1,603 registered users;
14 visitors (0 registered, 14 guests [including 4 identified bots]).
Forum time: 07:16 CET (Europe/Vienna)

The mediocre teacher tells.
The good teacher explains.
The superior teacher demonstrates.
The great teacher inspires.    William Arthur Ward

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz