Bioequivalence and Bioavailability Forum

Data for 2nd stage of Potvin’s designs [Two-Stage / GS Designs]

posted by BE-proff – 2017-02-18 07:40 (2618 d 03:15 ago) – Posting: # 17078
Views: 14,035

Hi All,

I have some questions on Potvin's designs:

1) is it correct that GMR and CV are required for sample size calculation for 2nd stage in all Potvin's designs?

2) Why Method C is considered "better" for sponsors than Method B?

The 1st question arised because Potvin's article dated 2007 says that only CV is needed for A and B while Method C uses both GMR and CV.

But on the other hand there are also opinions that all methods require GMR and CV.

Unclear....

Complete thread:

• Data for 2nd stage of Potvin’s designsBE-proff 2017-02-18 06:40 [Two-Stage / GS Designs] 
  • 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
        • Terminology Yura 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