Bioequivalence and Bioavailability Forum

Hi Mithu,

❝ 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.

Not sure if that is necessary if the ratio of plasma to stabilizer in CC/QC and study samples is kept the same.

For example,

- for study samples I added 100 uL of a buffer for every 1000 uL plasma collected before freezing.
- for bulk spiked CC/QC after spiking to desire concentration, I also add 100 uL buffer for every 1000 uL bulk spiked plasma before freezing.
-for analysis, I aliquot an equal volume of CC/QC and study samples for extraction. The stabilizer added should not change the true value. Am I right?

But adding the stabilizer directly to blood before plasma separation should be more complicated and I have never done it.

Regards,
Ladi