Bioequivalence and Bioavailability Forum

Dear Helmut,

Thanks for the reply. And as you said: Interested in other opinions!—Yes

Let us also discuss the regulatory prospective as now the regulators have started auditing the studies in these prospectives, they have started giving emphasis on these points. So I am asking views of yours that whether this should be a parameter for method validation as many CRO's are doing this already and can the inspectors make issue of this?

Regards,
Shuja

Dear Helmut,

Besides the general reqirement of validating stability in whole blood, there is the important question who should perform this validation. As analytical facilities take over responsibility at the point of sample arrival, in my opinion they have to validate their processing from this point. In fact they cannot be responsible for sample processing steps that are not subject to influence and documentation by the lab and that occur far distant in some clinical unit (you can't make the president of Iceland responsible for a riot in Timbuktu). And this poses a significant problem: The clinical unit, which has to validate these steps, frequently has not the possibility to analyze these targets. Additionally, as you already mentioned, there is usually a validated method for the processed plasma or serum, but not whole blood availlable. That means, that clinical units would have to send their validation samples to an analytical unit, which in turn must validate the analytics for whole blood. So, as a consequence, whole blood stability testing should not be regarded as an issue of analytical method validation, but of sample collecting. It is, in practical work of critical importance to separate these responsibilities.

regards
Hans Jörg