Bioequivalence and Bioavailability Forum

Thank you for your information.

Some analytical method developed in plasma matrix were published. And according to those references, they were also applied for BE studies. This makes me confused.

In the case that we have developed an analytical method for determination of Indapamide concentration in plasma and validated the method following FDA Guidelines for some criteria (specificity, sensitivity, accuracy- precision, linearity range, dilution integrity, carry over, matrix effect, stability…) like the others in which the analytes do not bind highly to red blood cells, is there any other addition criterion which has to be validated?

And please share with us some recommendations or some remarkable things while developing an analytical method in whole blood.

Thanks all!

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]