As data derived from the 30 pilot study samples were used to derive the acceptance criteria of equivalence, these were re-tested in the inter-laboratory comparison study to avoid the risk of over-estimating the concordance measures.
These statistics observed in the pilot study served as a reference for the true values of the parameters in the sample size calculations and a gauge in determining the pre-specified acceptance criteria of equivalence for the inter-laboratory comparison.
Data from each laboratory were selected to estimate inter-laboratory difference and duplicates within each laboratory were used to estimate the intra-laboratory difference and served as a basic assumption in deriving acceptance criteria of equivalence for the inter-laboratory comparison.
The obtained power was only robust for a large difference of d = 0.50 (two-tailed test, power 75%), which was well above our criteria of equivalence.
In order to assess such examples we need a criterion of descriptive equivalence.
Until now, the criterion of molecular equivalence within UniChem has been on the basis of complete identity between Standard InChIs.
The cross-validation processes included an experimental plan, sample size selection, and statistical analysis with a predefined criterion of method equivalence.
The primary and secondary objectives of the adult study were met: the pre-defined criteria for equivalence of Q-Pan and D-Pan vaccines were achieved at Day 21 and at Day 42 (Table 3).
An important early requirement for this service was that, as far as possible, and within the constraint of identity at the connectivity level, the user should be able to define for themselves their own criteria of molecular equivalence, since this may vary between users and areas of expertise.
In addition to representing important characteristics in studies of these taxa, all of the points chosen represent phylogenetic and ontogenetic homologs among the specimens, according to the criteria of topographic equivalence in primary homology [37].
