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RegisterAberrant observation in Reference (EU) for FDC [PK / PD]
Hello Friends,
What shall be done if T/R for single subject is around 1000 due to very low R value. No issues in clinical/bio analytical conduct.
As per EU we calculated whether its AUC is less than 5% of average GLSM for reference.
But the value comes to 5.80
Please guide. Will this work to exclude the subject. It was a FDC where in the concentration of second drug is 0 but may be our method for first drug was good enough
to measure these limited concentrations...
Edit: For beginners: FDC = Fixed Dose Combination (Product) [Helmut]
What shall be done if T/R for single subject is around 1000 due to very low R value. No issues in clinical/bio analytical conduct.
As per EU we calculated whether its AUC is less than 5% of average GLSM for reference.
But the value comes to 5.80
Please guide. Will this work to exclude the subject. It was a FDC where in the concentration of second drug is 0 but may be our method for first drug was good enough
to measure these limited concentrations...Edit: For beginners: FDC = Fixed Dose Combination (Product) [Helmut]
Complete thread:
- Aberrant observation in Reference (EU) for FDChiren379 2011-08-09 03:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Aberrant observation in Reference (EU) for FDC d_labes 2011-08-10 10:07
Ing. Helmut Schütz