Evaluation of Reference variability [Design Issues]

posted by Ohlbe – France, 2009-04-17 10:04  – Posting: # 3553
Views: 2,339

Dear Nirali,

» Shall it be appropriate design to evaluate reference variability for EU regulatory? :confused:

This was not the approach recommended at the EGA meeting last October. The preferred approach was to have a 3- or 4-period replicate study, with the reference administered twice, and the test once or twice. It seems that they are afraid that you might run a messy trial to show a high variability with the reference alone, and use these results to justify wider acceptance limits in a clean 2x2 trial with test and reference afterwards.


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