Bioequivalence and Bioavailability Forum

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❝ […] The general approach employed is that blood is collected into vacutainers which contain EDTA as an anticoagulant agent.

Why “general”? Vacutainers are available with various anticoagulants.

❝ Is it possible (does the guideline allow it?) for a lab to conduct full validation with spiked plasma samples, with citrate-phosphate buffer as anticoagulant, and then run the main study samples, with EDTA as anticoagulant and not face major invalidation issues during an audit?

No, IMHO.

❝ Would a series of QC samples, covering the whole quantification range, prepared by spiking EDTA-plasma be enough to prove that there is no interference?

I don’t think so.

❝ The same guideline later on states that only a partial validation is required when there is a change in the anticoagulant.

In such a case (change of anticoagulant) you may only skip those parts where the anticoagulant plays no role, e.g., stock solution stability, autosampler stability,…

❝ In the case that the guideline is binding regarding the above matter could someone propose a solution, as we have not been able to find large volumes of blank plasma (to be used for pre-study validation) which has been treated with EDTA.

You can get certified plasma with any type of anticoagulant from commercial sources. We routinely use samples for PAA Laboratories
(in Greece: KNT Biologiki, Korgialeniou Str. 1-3, 115 26 Athens, T 210-699-34-39, kntbiolotenet.gr).