Bioequivalence and Bioavailability Forum

Hi,

❝ How could I validate them?

To evaluate the stability of analyte(s) in whole blood, spike minimum of six replicates of LQC and HQC concentrations in the screened whole blood and keep these Stability samples at room temperature (or as specified in the protocol) for a period of minimum 6.0hr. Separate the plasma from spiked whole blood of respective concentration (LQC and HQC).

Process and analyze these samples along with separated plasma from freshly spiked six replicates of low & high quality control samples (comparison samples) in the screened whole blood. Calculate the percent stability for analyte(s) in the whole blood.

Centrifuge time and temperature are variable factors.