misunderstanding [RSABE / ABEL]

posted by mittyri – Russia, 2020-02-01 22:34 (1599 d 13:30 ago) – Posting: # 21127
Views: 19,364

Hi Mikalai,

❝ I am not fighting for money but for democracy, the Republic...

Republic of what?

❝ Your approach is nothing more than a road to hell lined with good intentions.

I think the reason of that words is the misunderstanding of arguments given above...

❝ Basically you advocate rejecting trials because of things that are neither legally prohibited nor have happened but are/were (when trials done) risky from one scientific angle.

There's no science in p value = 0.05. Or could you do me a favour and give some link where the contrary arguments exist? That's just a convention (given in GLs too). Rules of game. If you go there, please use it.

❝ Your approach basically gives experts the power to arbitrally decide which studies to accept and which do not.

:confused: where is it written? just to recalculate CIs using TIE correction gives the power? Is TIE some special value from expert mind? How do you think it is assessed?

❝ In Belarus, we often see this, and it usually ends that we have to prove that the globe is round not flat.

Could you please give some example? From the comments on the forum I can conlude that experts in Belarus are rather progressive.

❝ If TIE must be controlled in ABEL/RABE, it should be ingrained in regulatory documents. Full stop.

It should be controlled everywhere, not only in ABEL

❝ If somebody decided to risk and won (passing bioequivalence on ABE terms), these studies should be accepted.

Please define 'win'. You didn't win until null hypothesis(es) is rejected.

Otherwise, you would reject valid studies and would dictate how sponsors should spend their own money and how different countries have to vet BE trials.

Oh my! pity Sponsors!:-D

I propose not to spend money at all. Just go with pharmaceutical assessment, no BE study. no cent for useless trials. Is that approach reasonable enough?

❝ I am very skeptical that this decision tree can be outlawed

Are the arguments regarding TIE inflation not clear? WE are living in the real world where the precedence does not rule everywhere. And the experts also err. Maybe they didn't realize here the problem of TIE inflation. Remember that the problem is rather new.

❝ What is about ABEL/RABE trials when the CV is around 30% or uncertain but not small?

what are the benefits of replicate design for that CV value (30%)?

❝ Should we pump up the sample size in this case (I guess a majority of cases) to the level close to ABE trials which basically invalidates the whole concept of ABEL/RABE?

Have you read Helmut's calculations for the sample sizes?

❝ Finally, I am not a statistician

I think it is a good reason not to read the end of that paragraph, sorry...

Kind regards,

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