Bioequivalence and Bioavailability Forum • Common variance!

Common variance! [Design Issues]

posted by Helmut – Vienna, Austria, 2012-06-12 22:39 (5129 d 22:14 ago) – Posting: # 8721
Views: 11,241

Hi John!

❝ Could I hypothetically strip the two treatments (successful test formulation and the reference) and re-run stats in a two-way crossover fashion to re-evaulate the data?

(my emphasis)

See this goody (slides 60–67). The title ‘Don’t try this at home!’ tells it all. You are not the first one having such an idea (see also here).

❝ Would that stand a chance with regulatory?

Close to nil – unless you run sufficiently large simulations demonstrating that the patient’s risk is preserved. Not a trivial job.

—
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:

Curiosity: Running BE studies with more than 2 arms jag009 2012-06-11 15:01 [Design Issues]
- Common variance! Helmut 2012-06-11 16:23
  - Common variance! jag009 2012-06-11 17:25
    - Common variance! Helmut 2012-06-11 17:35
      - Common variance! jag009 2012-06-11 20:03
        
        Common variance! ElMaestro 2012-06-11 20:34
        
        Common variance! Helmut 2012-06-12 01:03
        
        Common variance! ElMaestro 2012-06-12 13:22
  - Common variance! jag009 2012-06-12 19:56
    - What if I run a study with 2 references? jag009 2012-06-12 20:00
    - Common variance!Helmut 2012-06-12 20:39
      - Two References d_labes 2012-06-13 09:11
        
        Two References jag009 2012-09-10 22:48
        
        Two treatments only d_labes 2012-09-11 08:20
  - Common variance! jag009 2012-06-13 16:08