Bioequivalence and Bioavailability Forum

Terminology [Two-Stage / GS Designs]

posted by Yura – Belarus, 2017-02-20 12:28 (3045 d 03:51 ago) – Posting: # 17088
Views: 15,177

Hi All,
If the ratio of AUC and Cmax T / R beyond 0.95 - 1.05, whether it is a violation of the conditions of the calculation for algorithm of adaptive design?

Complete thread:

• Data for 2nd stage of Potvin’s designs BE-proff 2017-02-18 06:40 
  • Data for 2nd stage of Potvin’s designs ElMaestro 2017-02-18 10:20
    • Data for 2nd stage of Potvin’s designs BE-proff 2017-02-18 13:29
      • GMR = fixed! Helmut 2017-02-18 16:23
  • “Type 1” slightly higher power than “Type 2” for the same adj. α Helmut 2017-02-18 11:51
    • “Type 1” slightly higher power than “Type 2” for the same adj. α BE-proff 2017-02-18 13:31
      • Terminology Helmut 2017-02-18 16:27
        • TerminologyYura 2017-02-20 11:28
          • Which GMR to plug in ElMaestro 2017-02-20 11:46
            • Which GMR to plug in BE-proff 2017-02-21 11:35
              • Which GMR to plug in ElMaestro 2017-02-21 11:47
          • Validated frameworks; observed GMR not relevant Helmut 2017-02-22 12:03
            • Validated frameworks; observed GMR not relevant Silva 2017-03-09 01:26
              • GMR, theta 0 and that all d_labes 2017-03-09 09:21
                • GMR, theta 0 and that all Silva 2017-03-09 12:38
                  • GMR, theta 0 and that all ElMaestro 2017-03-09 12:56
                  • GMR, theta0 and that all d_labes 2017-03-09 13:55
                    • GMR, theta0 and that all Silva 2017-03-09 18:01
    • “Type 1” slightly higher power than “Type 2” for the same adj. α BE-proff 2017-02-21 11:31