Russian «Экс­пер­тами» following the EEU GLs [Regulatives / Guidelines]

posted by Mikalai  – Belarus, 2018-01-04 11:43 (2360 d 12:35 ago) – Posting: # 18138
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Dear all
My name is Mikalai, and I am responsible for the conduct of bioequivalence studies in a medium-sized private pharmaceutical company in Belarus. Due to logistic issues (a small clinical center and a highly variable drug) we have to conduct a bioequivalence study in multiple groups (two). Our competent authority requires a justification not to include the group effect in the proposed statistical model. The groups will be separated by a week at maximum. It seems that we meet criteria set out by FDA to use a statistical model without including the group effect. Our competent authority can accept the FDA position on this issue, but we should properly reference it.

Thus, where can I find this information under FOI (link) or might it be possible that someone can share a copy of letter signed by Barbara Davit where it is outlined requirements to ignore the group effect in a statistical model?

Any help will be appreciated.
Sincerely, Mikalai


Edit: I moved your post from an answer to this one, deleted your email address, and activated personal messages in your profile instead. [Helmut]

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a research question, no matter how careful the subsequent
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