Bioequivalence and Bioavailability Forum • Usage of two different make instrument in Parallel study

Usage of two different make instrument in Parallel study [Bioanalytics]

posted by ElMaestro – Denmark, 2014-02-05 09:37 (4127 d 20:28 ago) – Posting: # 12339
Views: 4,881

Hi compliance,

❝ Is it advisable to run parallel study on two different make of instruments. I feel it is okay if we doing 2 way cross over but bit confuse about parallel design study analysis.

Shouldn't be an issue from an approval perspective as long as the use of both instruments is protocolled and validated. But it might increase variability and thus the width of the CI.
If we aren't talking instruments for bioanalysis but e.g. a medical device used to quantify a PD-endpoint then this situation would be reasonably common for a multi-center trial.

—
Pass or fail!
ElMaestro

Complete thread:

Usage of two different make instrument in Parallel study Compliance 2014-02-05 08:30
- Usage of two different make instrument in Parallel studyElMaestro 2014-02-05 08:37
  - Usage of two different make instrument in Parallel study Compliance 2014-02-05 13:10
    - Usage of two different make instrument in Parallel study Ohlbe 2014-02-05 14:28
      - Usage of two different make instrument in Parallel study Compliance 2014-02-07 04:38
        
        Deming-regression, Bland-Altman-plot Helmut 2014-02-07 13:46