Bioequivalence and Bioavailability Forum

Dear everyone,

I am developing a method to determine total iron and TBI for a BE study of iron sucrose.

I am targeting an LOQ of approximately 200 ppb Total iron/TBI. Given that human serum contains 500-1500 ppb TBI, how can one obtain the required concentrations of TBI (200 and 600 ppb) to validate the method? I have tried diluting the serum with saline but it didnt work.

Secondly, let's suppose that I manage to find some serum/plasma with low levels of iron among the ones available in my freezer, with the intention to use it for the validation of my method. How will I analyze it to establish the theoretical concentration since my method is not validated yet?

Finally, for a dose of 100 mg iron sucrose, what would be a satisfactory calibration range for total iron and TBI?

Thank you in advance,

stdev