Bioequivalence and Bioavailability Forum

Not to pool ;-) [Study Performance]

posted by Helmut – Vienna, Austria, 2008-11-25 13:25 (6013 d 04:47 ago) – Posting: # 2800
Views: 9,569

Dear Dlabes,

I agree to all your points, but without the information given later on in this thread I did not suggest to

❝ 1. Pool the studies...

I assumed that the sponsor made some modifications of the formulation and wants to make a comparison between studies - which is more powerful in a paired design (same subjects) than in a parallel design (different subjects).
Sometimes we've performed a new cross-over BE study and (exploratorily) made a comparision with the 'old' formulation between studies in order to support the chosen modification.

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Complete thread:

Same Volunteers In Two Different Studies shankar 2008-11-24 07:10
- Paired design Helmut 2008-11-24 14:32
  - Paired design BE 2008-11-25 06:01
    - Paired design d_labes 2008-11-25 10:06
  - Paired design shankar 2008-11-25 06:50
    - Repeated / previous study d_labes 2008-11-25 09:56
      - Repeated / previous study shankar 2008-11-25 11:12
        
        To pool or not to pool d_labes 2008-11-25 11:52
        
        Not to pool ;-)Helmut 2008-11-25 12:25
        
        Not to pool ;-) is best pooling d_labes 2008-11-25 13:14
        
        Not to pool is best billiards ;-) Helmut 2008-11-25 13:20
        
        Pool is to big d_labes 2008-11-25 13:28
        
        Repeated / previous study Ohlbe 2008-11-25 11:54
        
        Bioavailability Comparison shankar 2008-11-25 12:24
        
        Bioavailability Comparison Helmut 2008-11-25 12:29
        
        Bioavailability Comparison shankar 2008-11-25 12:45
        
        Non Regulatory Submission shankar 2008-11-29 07:06

Not to pool ;-) [Study Per­for­mance]

Complete thread:

Not to pool ;-) [Study Performance]