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,…
Assessing Content Uniformity
and Steven Novick2 (1) GSK, Research Triangle Park, NC, USA (2) MedImmune, Gaithersburg, MD, USA Abstract Content Uniformity tests are used to establish that the dosage units of a drug…
Acceptance Sampling
Fig. 20.1 Operating characteristic (OC) curve Figure 20.1 shows a vertical line drawn at the lot percent defective value of 1.5 %. The value on the vertical axis where the vertical line crosses…
Overview of Drug Development and Statistical Tools for Manufacturing and Testing
(15.1) If the investigator is concerned about some kind of departure from the model in (15.1), the center points can provide a test for such a departure, although it provides…
Lifecycle Approach to Bioassay
Fig. 17.1 Four parameter logistic regression with asymptotes A and D, 50th percentile C and slope B A model derived from Michaelis-Menten kinetics is the four-parameter logistic regression equation: (17.1)In…
In Vitro Dissolution Testing: Statistical Approaches and Issues
’s are dissolution values of individual units expressed as a % of label claim, are averages of n individual unit dissolution values tested up to that stage, gives the number…
Clinical Assays for Biological Macromolecules
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….
