EU: ABEL TIE?? [Two-Stage / GS Designs]

posted by mittyri – Russia, 2019-10-19 23:24 (731 d 21:52 ago) – Posting: # 20707
Views: 3,072

Hi Helmut,

» an update: Yesterday at the 4th Biosimilars Forum a participant asked whether simulation-based methods (control of the type I error in a sufficiently high number of simulations, i.e., 1 mio in each cell of a narrow grid of n1/CV combinations) are acceptable. Andreas Brandt (BfArM and observer at the BSWP) answered “No.”

sad story
BTW: in your lecture you suggested to adjust the CIs for ABEL due to TIE inflation. Is that also dead?
Does it mean that you cannot prove anything using sims??

Kind regards,
Mittyri

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