Bioequivalence and Bioavailability Forum • FDA & multiplicity

FDA & multiplicity [Design Issues]

posted by Helmut – Vienna, Austria, 2012-12-01 03:00 (4951 d 17:43 ago) – Posting: # 9651
Views: 24,767

Hi John,

❝ Zipped some absinthe while refreshing my PK memory this afternoon.

Nice stuff. Prefer it in the late evening. ;-)

❝ My old boss filed a 4-way nifedpine study and if I recall correctly the statistic was straight forward and FDA didn't come back with questions on multiplicity. I recalled we filed the product back in 1997 (Good old days when I was hired as an university summer intern).

Yeah, the mid-1990s – the golden age of MR nifedipine. Analysed ~20,000 samples if I recall it right.

—
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:

Two Tests with Same Reference Noha Abdeljawad 2012-11-27 08:18
- Crossover designs with more than 2 treatments d_labes 2012-11-27 09:51
  - Crossover designs with more than 2 treatments Noha Abdeljawad 2012-11-29 07:43
- Sounds wrong to me ElMaestro 2012-11-27 12:10
  - Sounds wrong to me Dr_Dan 2012-11-27 14:32
  - Sounds wrong to me Noha Abdeljawad 2012-11-29 07:52
- Two Tests with Same Reference jag009 2012-11-28 21:26
  - FDA & multiplicity Helmut 2012-11-30 14:04
    - FDA & multiplicity jag009 2012-11-30 15:16
      - FDA & multiplicity Helmut 2012-11-30 16:12
        
        FDA & multiplicity jag009 2012-11-30 22:47
        
        FDA & multiplicityHelmut 2012-12-01 02:00
        
        FDA & multiplicity jag009 2012-12-03 21:53
    - Multiplicity: Mixed feelings ElMaestro 2012-11-30 15:24
      - Multiplicity: Mixed feelings Helmut 2012-11-30 15:52
        
        Multiplicity: Mixed feelings martin 2012-12-03 09:24
      - Multiplicity: Mixed feelings kumarnaidu 2013-12-12 11:03
        
        More infos, please Helmut 2013-12-12 15:27
  - Two Tests with Same Reference Noha Abdeljawad 2012-12-03 08:29
    - Two Tests with Same Reference jag009 2012-12-03 15:35
      - X-way d_labes 2012-12-04 09:25
        
        design kvgreddy06 2013-12-19 15:32
        
        design kvgreddy06 2013-12-30 16:48
        
        design intuitivepharma 2013-12-31 06:44
        
        design kumarnaidu 2013-12-31 08:24
        
        Problematic design Helmut 2013-12-31 15:02
        
        Problematic design kvgreddy06 2014-01-03 14:46
        Problematic design kumarnaidu 2014-12-24 12:56
        
        Problematic design Helmut 2014-12-24 16:10
        
        Problematic design kumarnaidu 2014-12-26 05:38
        
        Two fully replicated designs? Helmut 2014-12-27 15:52