Bioequivalence and Bioavailability Forum

Dear Members

This is with regard to dilution factor to be applied during sample analysis;

In clinical phase, during the blood collection stabilizing agent was added at 10:1 ratio. The plasma was separated from the diluted blood samples. Hence during the bioanalysis a dilution factor of 1.1 was applied to all clinical samples.

The Calibration standards and Quality control samples were prepared with plasma collected from stabilized blood. Hence there is no further dilution of CC and QC samples; the dilution factor of 1.0 was applied to all CC and QC samples.

The query regard to the dilution factor to be applied for the sample having a concentration range of above upper limit of quantification (ULOQ) and to be diluted 2 times with plasma collected from stabilized plasma.

For example 100µL is the sample volume,

50µL of Clinical sample (1.1 times diluted) + 50µL of blank plasma was added (no analyte added to it)

Please recommend us the dilution factor to be applied for above example?

Thanks and regards,
Avinash Jain