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RegisterOutlier in BE study [Study Assessment]
Dear Amira,
Do you mean to say that these subjects did not have any sample collected later than 12 hours, or that their concentration was BLQ after 12 hours ?
In the first case: this would provide grounds for excluding them from the stats (should be pre-specified in the protocol). In the second case: you're in trouble.
❝ a BE study of standard design with truncated AUC 0-72, certain subject in one phase completed the samples up to 72 hours (test product) while in the other phase completed up to 12 hours (Reference product)
Do you mean to say that these subjects did not have any sample collected later than 12 hours, or that their concentration was BLQ after 12 hours ?
In the first case: this would provide grounds for excluding them from the stats (should be pre-specified in the protocol). In the second case: you're in trouble.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Outlier in BE study Amira Gouda 2020-04-28 15:36 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Outlier in BE study mittyri 2020-04-29 11:50
- Outlier in BE studyOhlbe 2020-04-29 15:19
- Outlier in BE study Amira Gouda 2020-04-29 16:35
- Missing samples Ohlbe 2020-04-29 17:02
- Missing samples Amira Gouda 2020-04-29 17:08
- Missing samples ElMaestro 2020-04-29 17:21
- Missing samples Amira Gouda 2020-05-01 23:50
- Missing samples ElMaestro 2020-04-29 17:21
- Missing samples Amira Gouda 2020-04-29 17:08
- Missing samples Ohlbe 2020-04-29 17:02
- Outlier in BE study Amira Gouda 2020-04-29 16:35
Ing. Helmut Schütz