Bioequivalence and Bioavailability Forum

❝ 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?

Actually i don't know. i have a method in which CC & QC's are prepared in acidified plasma, where in subject samples after the separation, stabilizer added to the samples. In that they have applied correction factor.

This is the point where actually i need to understand the correct practice.

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

i agree for the direct collection of blood with stabilized solution would also a point for understanding of correct process.

I can only comment that, not applying correction factor to the CC & QC is because it is containing known amount whereas in unknown samples little dilution to the samples will not be considered as true value.