Bioequivalence and Bioavailability Forum • Yes, however...

Yes, however... [Two-Stage / GS Designs]

posted by jatkins_5 – Philippines, 2014-11-01 00:20 (3887 d 00:29 ago) – Posting: # 13816
Views: 8,698

Hi ElMaestro,

❝ Yes, I would assume you can actually do that across some of the EU agencies.

Thanks, thats good to know..

❝ But how could you ever be in a situation where you'd wish to study a third product descriptively in a form of BE trial?

We'd actually want to compare C's pk data with A, in a non statistical way, for future marketing purposes.

Not sure I get everything here, and if you are asked how this approach influences the type I error do you have a good answer prepared?

I think it's time we review our stats for this. I haven't got a prepared answer, really. Perhaps a simulation might work?

Thank you very much for your valuable reply!

Jerry

Complete thread:

Two-stage three-treatment BE study? Oiinkie 2013-07-22 16:03
- 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