Bioequivalence and Bioavailability Forum

Hi John,

❝ Strange Question... Lets say I run clinical and bioanalytical at Lab A and the study fails. I have doubt about their analytical so I take the samples to another bioanalytical Lab "B". If the results from lab "B" are different and the study now passes, how do I go about justifying filing? Lets say both validation reports look good and the methods are acceptable.

I think, the justification of Lab B's result must be backward in the sense that you must refute Lab A's result first. If all is good at Lab A, and your audit or monitoring (deliberately using the m-word here, actually) does not indicate issues, then there would seem no reason to have analyses at Lab B done at all.

Further, let's hypothetically say a user of the bebac forum wonders about you having "doubt about their analytical"; such a user could think it would be beneficial to know what that doubt is all about, and to know if that doubt only popped up when Lab A's result was a non-pass. What would you hypothetically reply?