Bioequivalence and Bioavailability Forum • Incorporation of additional QC during subject sample analysis.

shreyas goswami
☆

India,
2024-03-12 10:22
(205 d 10:55 ago)

Posting: # 23902
Views: 2,194

Incorporation 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? :confused:

Kindly share your practice and inputs.

Regards,
Shreyas Goswami.

dshah ★★ India, 2024-03-12 18:56 (205 d 02:20 ago) @ shreyas goswami Posting: # 23906 Views: 1,796	Incorporation of additional QC during subject sample analysis. Post reply
	Dear Shreyas Goswami Even ICHM10 follows the same which is adopted by FDA and EMA. Regards, Divyen Shah

shreyas goswami ☆ India, 2024-03-13 10:30 (204 d 10:47 ago) @ dshah Posting: # 23907 Views: 1,740	Incorporation of additional QC during subject sample analysis. Post reply
	Dear Divyen Shah, Thanks for the response Is it acceptable to incorporate additional QC on the basis of AVG Cmax of analyzed subjects. or it should be evaluated by the concentration data of each period separately????? Regards, Shreyas Goswami

ElMaestro
★★★

Denmark,
2024-03-14 17:26
(203 d 03:51 ago)

@ shreyas goswami
Posting: # 23910
Views: 1,722

Incorporation of additional QC during subject sample analysis.

Post reply

Hi shreyas goswami,

❝ Is it acceptable to incorporate additional QC on the basis of AVG Cmax of analyzed subjects. or it should be evaluated by the concentration data of each period separately?????

Rather than thinking in terms of periods, I prefer to shift the focus to runs per se:
For every run you look at the QC response for the second set, and there should be unknowns (=PK-samples) falling above that QC level. Then the QC levels are well chosen.

If a run suddenly has all unknowns below the second QC level, then then right there is an issue you can nominate as a "risk", and thus it is time for a time-out and and update of the QC-levels. You might add a QC level somewhere between first and second level, depending on the actual observations in the run in question but with an eye also towards concentrations in the previous runs.

—
Pass or fail!
ElMaestro