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RegisterIncorporation of additional QC during subject sample analysis. [Bioanalytics]
Dear Members,
Seeking for better clarity
As stated in RDC27/2012 (ANVISA) "at least two QCs are within the range of measured concentrations." unlike other regulatory agencies where it is stated " At least two QCs should be below AVG Cmax".
How it should be evaluated during subject sample analysis for ANVISA submission studies?
Can we set pre defined criteria like....67% of total periods meet above mentioned criteria or it should be on the basis of average Cmax?
Kindly share your practice and inputs.
Regards,
Shreyas Goswami.
Seeking for better clarity
As stated in RDC27/2012 (ANVISA) "at least two QCs are within the range of measured concentrations." unlike other regulatory agencies where it is stated " At least two QCs should be below AVG Cmax".
How it should be evaluated during subject sample analysis for ANVISA submission studies?
Can we set pre defined criteria like....67% of total periods meet above mentioned criteria or it should be on the basis of average Cmax?
Kindly share your practice and inputs.
Regards,
Shreyas Goswami.
Complete thread:
- Incorporation of additional QC during subject sample analysis.shreyas goswami 2024-03-12 09:22 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Incorporation of additional QC during subject sample analysis. dshah 2024-03-12 17:56
- Incorporation of additional QC during subject sample analysis. shreyas goswami 2024-03-13 09:30
- Incorporation of additional QC during subject sample analysis. ElMaestro 2024-03-14 16:26
- Incorporation of additional QC during subject sample analysis. shreyas goswami 2024-03-13 09:30
- Incorporation of additional QC during subject sample analysis. dshah 2024-03-12 17:56
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