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Study Results [Study As­sess­ment]

posted by VSL - India, 2015-04-20 19:46  - Posting: # 14721
Views: 8,008

Dear All,
Please explain what to do if following results obtained in BE-Study:
  1. Study is passed in CI but mean T/R ratio is not within the 0.80-1.25.
  2. Study is passed in CI but there is significant p-value for treatment/period/sequence
Shall we submit the study to regulatory agencies?
Regards...
VSL


Edit: Category changed. [Helmut]

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