According to the AQbD principles defined in ICH Q2(R2), ICH Q14 and USP<1220> the number of sample prep and injections replicates should already be defined during the development stage of an analytical procedure.
USP <1210> provides statistical tools that can assist in identifying a suitable number of replicates considering not only the precision of repeated measurements, but also the bias part.
The actual goal should be to get a final result that is as close as possible to the true or expected value or at least to define a range where the true value can be expected with a specified degree of probability and uncertainty, in order to minimize the risk for a false positive or false negative outcome of the reported results.
Fusion QbD has now adopted the concept described in USP<1220> and provides an automated and simple-to-use solution in identifying the best replication strategy conditions.
