Bioequivalence and Bioavailability Forum • Still SF

Still SF [Two-Stage / GS Designs]

posted by VStus – Poland, 2016-10-11 11:10 (3176 d 16:08 ago) – Posting: # 16716
Views: 14,430

Hi Helmut,

❝ lucid words about SF and great ideas about hacking embeded Linux-machines. :-D

Well, it's a proven solution (not by me!), just not quite legal in most of civilized countries ;)

❝ In a TSD we have some chances to demonstrate BE already in the first stage. Hence, my personal recommendation for n₁ 75-80% of the fixed sample’s n.

After playing with data from other studies, I've made a suggestion that same recommendation is good single stage cross-over with 2 groups to keep the study safe or "conservative"... We can then demonstrate BE based on larger (first) group if requested by regulators.

Regards, VStus

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 protocol ElMaestro 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 SFVStus 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