Bioequivalence and Bioavailability Forum

Hello!

Sorry for my bad english!

❝ Here the trouble starts (see what I wrote above). What we are doing here is actually HARKing (Hypothesizing After the Results are Known). Not exactly but we definitely generate the Null from the data. Apart from the TIE-issues every product approved by RSABE/ABEL followed its own rules. From a consumer’s perspective this is not fortunate.

Yes, we generate hypothesis, but we loss any link of TIE with reality. We form hypothesis from variance estimate, but it is only estimate we don't know real variance. I can't imagine how to definite TIE in this case.

❝ Not sure what you mean here. Can you elaborate?

Of course. It it my description of situation I think that "HARKing" come to bioequivalce because it is very expensive to make BE with big sample size or make therapeutic equivalence and it is compromise between regulators and industry. And from my side HARKing is a bad statistics (yes: consumer’s perspective this is not fortunate), but it is discussible ... some persons recommending that HARKing not be taught by educators, encouraged by reviewers or editors, or practiced by authors