High-Throughput Screening Data Analysis
Screening phase # of replicates # concentrations/ sample Total # of different test samples Total # of wells Pilot 2–3 1 103–104 2⋅104 Primary 1 1 105–1.5⋅106 105–1.5⋅106 Confirmation (experiment…
Statistical Methods for Comparability Studies
Fig. 26.1 Decision tree—defining critical quality attributes comparability criteria The first step in comparability determination is defining the target CQAs (T). To assess manufacturing capability (ΔM), one must have two…
Statistical Considerations for Stability and the Estimation of Shelf Life
where T j denotes the j th time (typically given in months of storage), Y ij denotes the stability limiting response at the j th time for the i th…
Recent Research Projects by the FDA’s Pharmacology and Toxicology Statistics Team
Tests for positive trend Control-high pairwise comparisons (one-tailed) Standard 2-year studies with 2 species and 2 sexes Common and rare tumors are tested at 0. 005 and 0. 025 significance levels,…
