Incorporation of additional QC during subject sample analysis. [Bioanalytics]

posted by shreyas goswami  – India, 2024-03-12 10:22 (39 d 00:29 ago) – Posting: # 23902
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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? :confused:

Kindly share your practice and inputs.

Regards,
Shreyas Goswami.

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