Bioequivalence and Bioavailability Forum

Bingo! [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2013-07-29 13:32 (4706 d 09:39 ago) – Posting: # 11099
Views: 11,650

Hi Oiinkie,

❝ To avoid the "too progressive" design of a two-stage three-treatment study, we will go for a three-treatment pilot and base our decision for the test formulation on this study.

Good idea. Given the strange responses I have seen in the recent past from European regulators even on straightforward two-stage designs I would not recommend such an approach – unless a framework is published. Nevertheless, a tempting idea which deserves some attention, IMHO.
( ElMaestro?)

—
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Helmut Schütz


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Science Quotes

Complete thread:

• Two-stage three-treatment BE study? Oiinkie 2013-07-22 16:03 [Two-Stage / GS Designs] 
  • Bingo! Helmut 2013-07-22 16:33
    • Bingo! Oiinkie 2013-07-29 10:41
      • Bingo!Helmut 2013-07-29 11:32
        • Bingo! ElMaestro 2013-07-29 12:06
        • Terms in Anova ElMaestro 2013-07-29 16:50
          • annoying imbalance ElMaestro 2013-07-29 22:37
    • Bingo! jatkins_5 2014-10-30 03:53
      • Yes, however... ElMaestro 2014-10-30 08:59
        • Yes, however... jatkins_5 2014-10-31 23:20