Bioequivalence and Bioavailability Forum

Replicated 4×2 and two-stage-design, in the same protocol [Two-Stage / GS Designs]

posted by ElMaestro – Denmark, 2015-04-06 10:53 (3305 d 15:10 ago) – Posting: # 14661
Views: 15,800

Hi Mauricio,

❝ Is it possible? Or I am crazy in front of the statistic and statisticians? :confused:

Combining 2-stage and replicated studies in one protocol is hitherto undescribed in the scientific literature. So you likely do not know how the type I error is controlled or how your method performs in terms of power/sample sizes. If the agency asks you to give proof that the Type I Error is controlled you might be somewhat doomed?

There appears to me to be no reason why it wouldn't work, though. It just needs to be investigated and reported.

—
Pass or fail!
ElMaestro

Complete thread:

Replicated 4×2 and two-stage-design, in the same protocol Mauricio Sampaio 2015-04-06 08:37
- Replicated 4×2 and two-stage-design, in the same protocolElMaestro 2015-04-06 08:53
- Science fiction Helmut 2015-04-06 14:20
  - Science fiction Dr_Dan 2016-03-04 10:33
    - Science fiction furthermore d_labes 2016-03-04 13:21
    - Still SF Helmut 2016-03-04 13:41
      - Still SF VStus 2016-10-06 21:08
        
        Still SF ElMaestro 2016-10-06 22:13
        
        Still SF VStus 2016-10-06 22:53
        Still SF VStus 2016-10-11 10:23
        
        Still SF Helmut 2016-10-07 10:38
        
        Still SF VStus 2016-10-11 09:10
- mindblowing ElMaestro 2016-10-11 07:44
  - Natural constant as usual; not for reference-scaling Helmut 2016-10-11 09:50
    - Consistency DavidManteigas 2016-10-11 11:25

Replicated 4×2 and two-stage-design, in the same pro­to­col [Two-Stage / GS Designs]

Complete thread:

Replicated 4×2 and two-stage-design, in the same protocol [Two-Stage / GS Designs]