Bioequivalence and Bioavailability Forum

Dear Pramod,

According to the http://www.fda.gov/cder/guidance/4252fnl.pdf FDA guideline on bioanalytical method validation, page 15:

Standards and QC samples can be prepared from the same spiking stock solution, provided the solution stability and accuracy have been verified.

You can use the same stock solution for calibration and QC samples. But you have to show that the stock solution was prepared correctly and that its concentration is accurate. Which is usually done by comparing it to another, independently prepared stock solution...

Regards
Ohlbe

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Edit: Link corrected for FDA’s new site. [Helmut]