Bioequivalence and Bioavailability Forum

mindblowing [Two-Stage / GS Designs]

posted by ElMaestro  – Denmark, 2016-10-11 09:44 (3176 d 12:08 ago) – Posting: # 16714
Views: 14,460

I think I overlooked this:

This was a two stage, four period, cross-over, block randomized, replicate design, single dose bioavailability study in healthy volunteers without charcoal blockade. Forty-eight healthy volunteers (24 males and 24 females, aged 18-55 years) were enrolled in the first stage according to study protocol.
Bioequivalence was reached at the first stage according to protocol; therefore the second stage of the study was not required to be performed. There were four periods in the first stage: both test and reference product were given twice according to a replicated design.

Alpha 2.94%. Approved in Germany, Sweden, Portugal, Iceland, Hungary, Italy, 2015

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 SF VStus 2016-10-11 09:10
  • mindblowingElMaestro 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