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RegisterReplicate Study designs [Outliers]
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
Dan
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
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Replicate Study designs balakotu 2014-01-08 08:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Replicate Study designs Dr_Dan 2014-01-08 09:54
- Replicate Study designs Mahesh M 2014-01-08 13:18
- Replicate Study designsDr_Dan 2014-01-08 15:24
- Replicate Study designs jag009 2014-01-08 15:33
- Re-testing Helmut 2014-01-08 16:16
- Replicate Study designsDr_Dan 2014-01-08 15:24
- Replicate Study designs Mahesh M 2014-01-08 13:18
- Replicate Study designs Ohlbe 2014-01-08 14:24
- Replicate Study designs Dr_Dan 2014-01-08 09:54
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