Bioequivalence and Bioavailability Forum

Hello Akinapally,

❝ What is the impact on the study out come(Bio-analytical results) for a BA/BE study in the following case.

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❝ Case1: If i use 3ml K3EDTA vacutainer (if i don't have 2ml vacutainer) for 2ml sample?

If you are able to somehow collect 2 ml into a 3 ml tube:
The plasma you process may contain 50% more K3EDTA, this change could at least in theory be significant to the downstream processing of the sample. I would advise that this phenomenon be evaluated e.g. as a kind of ruggedness test in the bioanalytical validation.

If you collect 3 ml (or what could subjectively by others than yourself be considered a quantitatively larger amount than 2 ml) into a 3 ml tube:
While the bioanalytical result may not be affected per se, I'd have some potential worry since the protocol would usually specify that you are collecting 2 ml samples and XYZ ml in total per period. Collecting more may be a protocol violation.