Bioequivalence and Bioavailability Forum • Bioavailability Comparison

Bioavailability Comparison [Study Performance]

posted by Helmut – Vienna, Austria, 2008-11-25 13:29 (6013 d 04:59 ago) – Posting: # 2801
Views: 9,570

Dear Shankar!

❝ They are not informed us that which authority they are going to submit.

That's bad business conduct. Since guidelines vary between countries you are left out in the rain.

❝ The aim of this study is to compare the Pharmacokinetic behaviour

❝ (Bioavailability) of drug in same volunteers in two different studies.

IMHO that's not a valid rationale for a study according to ICH E6 and E9...

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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 ComparisonHelmut 2008-11-25 12:29
        
        Bioavailability Comparison shankar 2008-11-25 12:45
        
        Non Regulatory Submission shankar 2008-11-29 07:06

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