Bioequivalence and Bioavailability Forum

Hi All,

I request you all to correct me if my below mention understanding is not correct.

As per my understanding, whenever we add any stabilizer in study samples immediately after collection of blood samples or after getting plasma separated from the blood we add the stabilizer, we should apply correction factor to the obtain unknown concentrations.

This factor needs to apply only to study samples not to CC & QC prepared. The rational what i believe for this is, unknown samples get little diluted due to addition of stabilization solution and it will not produce true value. Whereas the CC & QC which are also stabilized but here we have known concentration, hence correction factor is not needed to apply because we have % nominal for the acceptance or rejection of the same.

Hence the correction factor applies to get the correct or true concentration of unknown samples only.

Regards,

Mithu