Bioequivalence and Bioavailability Forum

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

posted by Mauricio Sampaio  – Brazil, 2015-04-06 10:37 (3301 d 08:14 ago) – Posting: # 14660
Views: 17,713

Are there any problem if, in the same protocol, replicated 4x2 and two-stage-design are considered?

For example, in first group were used 96 subjects on replicated (4x2) design with IC 95%. The result wasn't bioequivalent and the power was less than 80%. Therefore, a second group was added with 48 subjects, on replicated (4x2) design with the same IC 95%. In the end, first and second stage were combined and the result was bioequivalent.

I am to consider this strategy because I don't know how much variability of drug is that! But I would like to save money in the first moment risking a short number of subject and to have a opportunity to increase this number in the same study of bioequivalence.
Is it possible? Or I am crazy in front of the statistic and statisticians?

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Edit: Category changed. [Helmut]

Complete thread:

• Replicated 4×2 and two-stage-design, in the same pro­tocolMauricio 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
  • 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