Bioequivalence and Bioavailability Forum • EU: ABEL TIE??

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

posted by mittyri – Russia, 2019-10-19 21:24 (572 d 06:21 ago) – Posting: # 20707
Views: 2,548

Hi Helmut,

» an update: Yesterday at the 4^th 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

Complete thread:

EU, method C preference ElMaestro 2019-10-11 10:25 [Two-Stage / GS Designs]
- On the contrary, my dear Dr Watson! Helmut 2019-10-11 11:52
  - On the contrary, my dear Dr Watson! nobody 2019-10-11 17:39
    - On the contrary, my dear Dr Watson! Helmut 2019-10-11 17:47
      - On the contrary, my dear Dr Watson! ElMaestro 2019-10-11 18:01
        
        On the contrary, my dear Dr Watson! nobody 2019-10-11 18:08
        On the contrary, my dear Dr Watson! Helmut 2019-10-11 18:11
- EU: simulation-based methods in agony Helmut 2019-10-19 12:38
  - EU: ABEL TIE??mittyri 2019-10-19 23:24
    - Reference-scaling: only simulations possible Helmut 2019-10-20 13:58