Trying your model for EEU [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-01-05 01:06 (2351 d 11:20 ago) – Posting: # 18145
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Hi Mittyri,

❝ You are Key Opinion Leader in Russia (not limited to Russia I believe)

Hhm. :ponder:

❝ ❝ Nobody tried model II without a pre-test (this would be a much better option than the FDA’s step-wise models). Why? Duno.

❝ Why do you think that nobody has tried? :-D

In Yaroslavl I specifically asked the participants. Maybe the ones you know were there but didn’t want to come up in front of the experts?

❝ Talked to some involved guys, they are trying and waiting for experts feedback

Great. Let’s keep our fingers crossed.

Also in Yaroslavl people encouraged me to publish my meta-study. Well, I’m still collecting data (:waving: Astea). They also suggested a Russian Journal. I don’t like that, since seemingly Russian is more ambiguous than English. Originally I thought of the Journal of Biopharmaceutical Statistics (where Pina D’Angelo’s article about carry-over was published). When I presented about Multi-Group Studies at the 2nd Annual Biosimilars Forum (October 2017) everybody (and this was a statistical audience from agencies, the industry, and CROs) was surprised that it is an issue at all. Nobody (!) would expect anything than simple pooling. The consensus was that the FDA’s stage-wise procedure might even inflate the Type I Error and should be avoided. Given that I guess such a manuscript will be rejected right away due to its doubtful content. :-D

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