The EMA’s BSWP’s opinon [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2016-03-04 15:37 (2102 d 08:28 ago) – Posting: # 16051
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Dear all,

last month I had the displeasure to attend a “scientific” advisory meeting at a Scandivian agency.

Background:Maximum TIE was 0.04987. Power generally >80% unless the very unlikely combination of extremely different group sizes and CVs hits. Even then ~70%. I was satisfied.

The agency’s statistician said (my comments in blue):
The work plan 2016 of the BSWP contains this:

Type I error control in two-stage designs in bioequivalence studies
Action: Continue work related to type I error control in two-stage designs in bioequivalence studies.
Comments: This is done in collaboration with the Pharmacokinetics Working Party.

I fear the worst. But where is the secret recommendation? Today Rev. 13 of the Q&A document was published. Nada.



Dif-tor heh smusma 🖖
Helmut Schütz
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