Bioequivalence and Bioavailability Forum

Still SF [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2016-10-06 22:13  – Posting: # 16702
Views: 10,383

Hello VStus,

» But back to reality: isn't it more practical in case of HVD to perform pilot on development with let's say 50% power (wondering: replicated pilot to keep reasonable small population?), better understand in-vitro in-vivo relationship, optimize formulation and than run replicate scaled trial? In 2-stage we also need to wait for results from the 1st stage...

Yes
Nitpicking: you perform a 2-stage trial or a pilot trial because you do not know the variability, right? Which means the "let's say 50% power" in actuality means guessworking. Optimizing the formulation on basis of a pilot trial with inherently low power (=high uncertainty on the PE) is in scientific terms as solid as tarot cards or crystal healing.
I read on LinkedIn the other day: "The flat earth society has members all over the globe"

OK, surely I will get in trouble for this post.

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 SFElMaestro 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