Bioequivalence and Bioavailability Forum

Two-Stage Sequential Designs [Two-Stage / GS Designs]

posted by Helmut  – Vienna, Austria, 2010-05-21 03:06 (5511 d 16:31 ago) – Posting: # 5361
Views: 16,385

Dear bears!

Language is a virus.*

❝ [...] you say FDA will accept... not now?

"Will accept" is as correct as "would have already accepted" in the past – but since not a single study (!) was submitted to the FDA until now, Barbara talked about the future. She was actually somehow surprised that nobody did so until now. She also pointed out that Donald Schuirmann is one of the coauthors of the paper – so FDA is pretty confident with the applicability. On the other hand they recently received a study based on the original work of Pocock (1977)…

❝ Potvin et al. (2008) said "...the FDA has accepted studies with designs like those considered here..." (p.259) in their article.

Also asked and confirmed.

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• William S. Burroughs

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

• Two-Stage Sequential Designs Helmut 2010-05-20 16:53 
  • Two-Stage Sequential Designs yjlee168 2010-05-20 21:28
    • Two-Stage Sequential DesignsHelmut 2010-05-21 01:06
      • EMA: Two-Stage Sequential Designs d_labes 2010-06-15 16:02
        • EMA: Two-Stage Sequential Designs Helmut 2010-06-15 16:23
          • EMA: Two-Stage Sequential Designs The Outlaw Torn 2011-10-20 10:30
            • EMA: Two-Stage Sequential Designs Helmut 2011-10-21 15:01
              • PAR? ElMaestro 2011-10-21 15:23
                • PAR not yet Helmut 2011-10-21 16:02
                  • PAR not yet The Outlaw Torn 2011-10-25 08:57
                    • PAR not yet The Outlaw Torn 2011-10-27 11:07
                      • Potvin C not acceptable! d_labes 2011-10-27 13:16
                      • PAR not yet ElMaestro 2011-10-27 13:25
                        • PAR not yet The Outlaw Torn 2011-10-31 07:45
                          • No (?) comment :-( Helmut 2011-10-31 15:04