Bioequivalence and Bioavailability Forum

Good morning,

Background:
Steady state BE study with SR product.

Study results:
AUCt ratio is high 90s (90% CI well within limits)
Cmax ration is low 100s (90% CI well within limits)
Cmin ratio is high 70s (Lower 90% CI limit of 73)
Fluctuation ratio is high 110s (90% CI within limits)

I believe that although Cmin failed to meet bioequivalence criteria, an argument can be made that the product is bioequivalent based on fluctuation. My concern is whether we have a strong enough justification in making such a claim (post-hoc argumentation aside). Any opinion and feedback would be greatly appreciated. If additional information is necessary to provide a more educated response, please let me know.

I'm also interested in a little education on the meaning of Cmin in steady state BE studies if anyone is predisposed to provide it.

Thank you all in advance.

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Edit: Category changed. [Helmut]