Bioequivalence and Bioavailability Forum • Potvin C or B?

Potvin C or B? [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2012-06-02 20:54 (4766 d 21:31 ago) – Posting: # 8656
Views: 13,137

Gossip:

One regulator (I leave it to your imagination which one of EMA’s working parties he belongs to) told me that

Our [i.e., his agency’s] statisticians don’t believe^* that in Potvin’s Method C the patient’s risk is preserved at ~5%. They suggest to use only Method B because application of Pocock’s α 0.0294 is well known.

I suggested to tell them to have a closer look at the empiric alphas (the endless tables in the paper). BTW, specifically Method C (not B!) is recommended by the FDA and in the recent Canadian GL.

Quoting my late father: “If you don’t want to know, but to believe – go to church.” Was in the 1960s; so for the sake of political correctness add temple, mosque, synagogue, stupa, pagoda, shrine, Lenin’s mausoleum, …

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

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Complete thread:

Potvin C or B?Helmut 2012-06-02 18:54 [Two-Stage / GS Designs]
- Belive in Potvin C? d_labes 2012-06-04 10:34
- Potvin C or B? ElMaestro 2012-06-05 11:45
  - Potvin C or B? Helmut 2012-06-07 15:45
    - Potvin C or B? ElMaestro 2012-06-07 17:01
      - Potvin C or B? Helmut 2012-06-07 18:28