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RegisterDB Summary Table 9 [Bioanalytics]
Pharmacokinetic outlier
I think it is important to have an SOP in place and issued prior to running the study. It should be defined what the criteria are for identifying a "pharmacokinetic outlier" and repeat of the assay. The repeat data should be examined in accord with the lab. SOP for accepting and rejecting repeat assays.
The FDA will review above.
Angus
I think it is important to have an SOP in place and issued prior to running the study. It should be defined what the criteria are for identifying a "pharmacokinetic outlier" and repeat of the assay. The repeat data should be examined in accord with the lab. SOP for accepting and rejecting repeat assays.
The FDA will review above.
Angus
Complete thread:
- PK profile outlier avinash 2013-05-02 14:48
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IS response? Helmut 2013-05-02 14:56
- IS response? avinash 2013-05-02 15:09
- DB Summary Table 9 Helmut 2013-05-02 15:17
- DB Summary Table 9AngusMcLean 2013-05-15 00:38
- DB Summary Table 9 Helmut 2013-05-02 15:17
- IS response? avinash 2013-05-02 15:09
- IS response? Helmut 2013-05-02 14:56
Ing. Helmut Schütz