Bioequivalence and Bioavailability Forum • Two-Stage Sequential Designs

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

posted by yjlee168 – Kaohsiung, Taiwan, 2010-05-20 23:28 (5881 d 05:20 ago) – Posting: # 5358
Views: 19,255

Dear Helmut,

Thanks for your great news. But you say FDA will accept... not now? Potvin et al. (2008) said "...the FDA has accepted studies with designs like those considered here..." (p.259) in their article.

—
All the best,
-- Yung-jin Lee
bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

Two-Stage Sequential Designs Helmut 2010-05-20 16:53 [Two-Stage / GS Designs]
- Two-Stage Sequential Designsyjlee168 2010-05-20 21:28
  - Two-Stage Sequential Designs Helmut 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