Bioequivalence and Bioavailability Forum

Dear nobody,

I'm from Mexico and like you I'm still searching for that...

❝ "modified release guideline" mentioned under 8.4.16.3... Good luck!

Regarding the bioequivalence legislation in my country for me is kind of disappointing, we have to wait almost 15 years (15 years!) to update the only guidance that exists in this country of BE studies to got (IMHO) a bad copy of other guidances mainly both in the statistical part.

And like Helmut says our mexican guidance has a "wacky" statistical approach on bioequivalence trials, mainly because there is a mix of add-on with two-stage design .

There is other point on this guidance that I like to share with you and I would like to know your point of view:

On the 9.6.7. indicate "The power of the study should be reported, which will be only of informative character when the conclusion of the study is bioequivalence between the drug products". That, for me ,is "No matter what power do you got on your study, if the confidence interval of your study it's between 80 - 125% the drug products are bioequivalent" I'm not an expert on bioequivalence statistics but for me not taking in consideration the statistical power of the study even when the 90CI% complaint with 80-125% put a serious question of the therapeutic effectiveness of the drug products that will be avaliable on the market.

Finally, our mexican guidance it is available only in Spanish and it is a "must do legislation" not a guidance if you don't do what it says you are in serious troubles with everybody .

Regards,
Risherd.