Bioequivalence and Bioavailability Forum

Hi GM,

❝ »This means, whether we have to replace BQL values with "zero" or can we keep as it is in the BE analysis without replacing those values with zero?

You list them as BQL's (or similar), not as zeros. The true bottleneck is how the software handles it.

❝ So, if we consider measured(BQL) values as it is for the calculation of AUC, are there any comments come from regulatory?

Depends on how the software handles the BQL's and if regulators agree with the way it does. They don't often re-calculate the NCA in Europe, but often do so in the US.

❝ We don't have any SOP and protocol also states that, follow Bioanalytical guidance.

Then how do you now if you want to do lin up, log down or lin up, lin down? Even if you use default settings with commercial software I'd always recommend you to have in your SOP that this is your active choice. Having it in a protocol may achieve the same in practice, but the contents of the protocol can be said not to be part of your QMS.

❝ If we keep measured values(BQL as it is) in input data, software will consider those values for the derivation. B'coz we are not providing any cutoff value for BLQ in the input data.

It is very vague to me what you are saying. What does the software actually do behind the scenes, and do you agree with what it does? If so, then there's no issue really, am I right?