Bioequivalence and Bioavailability Forum • EU, method C preference

EU, method C preference [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2019-10-11 12:25 (2436 d 17:19 ago) – Posting: # 20683
Views: 10,375

Hi all,

I remember having heard EU regulators mention preference for method C out of consideration for the type I error. But I can't seem to find a presentation from anyone saying so. Do you know, do one of you experts have a link or a presentation by a regulator where this was stated?

Many thanks.

—
Pass or fail!
ElMaestro

Complete thread:

EU, method C preferenceElMaestro 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