Replicate Study designs [Outliers]

posted by Dr_Dan  – Germany, 2014-01-08 16:24 (3434 d 07:56 ago) – Posting: # 12149
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Dear Mahesh M
Just for clarification: when I talked about outlier verification I did not mean a statistical test but rather a re-dose study (you administer test and reference in a cross-over design in the outlying subjects together with a certain number of other study participants). However this is only possible for FDA submissions. For EU submissions Ohlbe is right, the study failed.
Kind regards

Kind regards and have a nice day

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