Bioequivalence and Bioavailability Forum

Dear Loky do,

❝ What are the potential implications of mistakenly designing the QC high at 70% of the upper limit and analyzing study samples based on this? Would re-validation and reanalysis of all samples be required, or could this deviation be accepted by regulatory authorities?

You mean, 70% instead of "at least 75%" according to M10 ?

Doing a partial validation with a higher level of concentration will not hurt (particularly, ME, P&A and stabilities).

If the samples have already been analysed, look at how the concentrations fit compared to your QCs. If all or most concentrations are below the HQC, you can have a good argument to say that no impact on the trial data is expected. Actually if you follow M10 §3.3.3, you can adapt the concentrations of the QC samples if you have a narrow range of concentrations in the study samples. It is supposed to be something deliberate, not kind of oooopppsssy, but it could help to justify. Overall and unless you have tons of samples with a high concentration, or problems in the partial method validation, I would not expect any need to re-analyse the samples.