I remember the presenter saying that in situations where you don't have adequate sample analyte to cover the whole specs range you can use extrapolation. Is this the extrapolation defined in the guidelines whereby a certain percentage of the lower and higher ends of the spec range are used, or you do it as your situation allows? I do see that for some assays the analyte on both ends still do not meet the specs range on the recommended lower and higher ends in the ICH guidelines. This is because the samples are limited. I have an example where the ICH guidelines recommend 80% of the lower end of the spec and 120% of the higher end. If this is still off, based on your samples, are you expected to extrapolate by calculation based on how linear your data points are? It's still quite a confusion for me.
The guideline does not go into details. Of course, you must take into account the samples and ranges that are available or accessible. Whether or not to extrapolate by calculation depends on your samples. In case of accuracy (recovery) with several concentrations, this may be possible. In case of precision with authentic samples at a target concentration, you have to extrapolate the conclusion of an acceptable precision at the target concentration over the whole range.
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