Bioequivalence and Bioavailability Forum

¡Hola Risherd!

❝ 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 […]

Well, others don’t perform much better.
FDA: 1992 → 2003 → 2013 (draft; nobody knows when it will be finalized)
EMA: 1992 → 2001 → 2010 (a little bit quicker)

❝ 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’s good. I like this statement. Really!

❝ 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" […] 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.

No; although this is a common misconception. Power is only related to the producer’s risk. Let’t say you planned the study for 80% power (= 20% risk of failure). The study passes BE, but ‘power’ is just 60%. You were lucky, but you made it. No, the risk is not 40%. You succeeded (to 100%, if you like).
The patient’s risk is still 5%.

❝ 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 .

It’s a brilliant idea to give technical details in a law. In the first Brazilian regulation the definition of bio­avail­abi­lity was wrong and it took them five years to change a single sentence.