Bioequivalence and Bioavailability Forum • Two-stage (classical Pocock) and the FDA

Two-stage (classical Pocock) and the FDA [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2011-10-31 03:36 (4983 d 14:22 ago) – Posting: # 7561
Views: 18,750

Dear all!

Have you ever wondered what the last sentence is based upon?

Methods B and C meet our criteria of not more than minimal inﬂation of type I error rate. We recommend that regulatory agencies accept either. It is our understanding that the FDA has accepted studies with designs like those considered here.

Mystery revealed here.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

2-stage design - power evaluation d_labes 2011-10-12 11:10 [Two-Stage / GS Designs]
- No opinions out there? d_labes 2011-10-26 09:14
  - Opinion yes, answer no ElMaestro 2011-10-26 11:15
    - Decision scheme without (?) power check d_labes 2011-10-26 13:00
      - Decision scheme without (?) power check ElMaestro 2011-10-26 13:20
        
        Decision scheme 'without' power check d_labes 2011-10-26 14:51
        
        Decision scheme 'without' power check ElMaestro 2011-10-26 15:24
        
        Numerical example d_labes 2011-10-26 16:28
        
        Numerical example ElMaestro 2011-10-26 16:49
        
        Potvin C with unsymmetrical alphas d_labes 2011-10-27 14:54
        
        Potvin B, C, or D? Helmut 2011-10-27 22:52
        Two-stage (classical Pocock) and the FDAHelmut 2011-10-31 02:36
- Weirdo paper ElMaestro 2011-11-30 18:04
  - Weirdo paper Helmut 2011-11-30 23:45
    - Weirdo paper ElMaestro 2011-12-01 07:16