Bioequivalence and Bioavailability Forum

Hi Konkous,

❝ Is there a specific procedure describing how whole blood samples should be treated during the interval between sampling and centrifugation? I'm referring to a BE study and to be more specific i need to know if there are any guidelines describing temperature conditions or some kind of shaking of blood samples in the vacutainers before they are centrifuged. For example if someone claims that blood samples remain at room temperature for 20 min before being centrifuged should he expect that an auditor would raise stability issues?

As I see it, this should all be detailed out in your own analytical protocol / method description. You can chose the conditions under which the assay is being run and to which the validation as well as the study adheres.