Fig. 11.1 Typical multi-tiered immunogenicity testing approach employed in clinical trials Screening Assay In the screening tier of immunogenicity testing, the samples responses are compared against the screening cut point….
, xi being one reportable result as an estimate of μ. Bias—or trueness—of an assay on the other hand is the difference between the average of many reportable results (i.e….
, which says that the result of any measurement, y, has two components. The first, f(x), is the signal or what the controlled factor or factors are, and the second,…
– 2.2*s) <115 %, where and s respectively are the sample mean and the sample standard deviation of the 10 units. It fails to comply if at least 1 unit has the…
Fig. 13.1 A ray or fixed ratio design for two drugs in combination studies This design is typically used in industry for in-vitro studies. A third design (Tan et al….
Fig. 18.1 Building blocks of quality by design Table 18.1 Descriptions of the building blocks of quality by design Building block Description Critical quality attributes (CQAs) The critical process output…
Fig. 8.1 Basis for QTiSA-HT cardiac liability assay. The upper panel depicts a ventricular action potential, an electrical response of a ventricular myocyte plotted as the change in transmembrane potential…
is the 100(1-α)th percentile of the F distribution with (2x + 2) and (2n − 2x) degrees of freedom. Then Table 19.1 Consumer’s and producer’s risk quality points for potential PPQ acceptance sampling plans…
Fig. 25.1 NMR spectra before and after pre-treatment In order to eliminate the effects caused by the differing magnitudes of different variables, auto-scaling (or center and scale) can be used….
Fig. 10.1 Flow chart for sequential trend testing The advantage of trend testing methods is that for monotonic dose–response patterns, the methods are more sensitive than pairwise comparisons alone. Note…
