1.1. New Procedures and Features
Additional Features in major Release 10
A new Outlier Tests procedure is available under the Goodness of Fit Tests menu. One and two-tailed Dixon, Grubbs and two-tailed ESD (Generalised Extreme Studentised Deviate) tests are supported, complete with critical table values and Pass / Fail test results. See section 6.3.4. Outlier Tests.
UNISTAT license activation application is now also provided under the Tools menu option. See section 2.4.5. Activation.
Additional Features in Bioassay module
UNISTAT’s Bioassay module now complies with FDA 21 CFR Part 11 requirements. See section 10.0.5. Compliance Options.
A new optional variable type [Assay] is introduced to all bioassay methods which makes it possible to run multiple assays and combine their results with a single click. See section 10.0.4. Multiple Assays with Combination.
A new optional variable type [Dilution] is introduced to all bioassay methods, which enables the user to enter assigned potency of the standard, assumed potency of each test preparation and pre-dilutions for all preparations including the standard. UNISTAT will then calculate the estimated potency as described in sections 10.0.2. Doses, Dilutions and Potency and 10.0.3. Potency Calculation Example.
A wide range of tests and graphics options are included under a new Validity of Data option for Parallel Line Method and Slope Ratio Method. Available options are Summary Statistics, Normality Tests, Homogeneity of Variance Tests, Outlier Tests, Box-Whisker, Dot and Bar Plots and Normality Plots.
All bioassay procedures now feature a Case (Diagnostic) Statistics output option, displaying actual and estimated response variables, residuals and standardised residuals, which are useful for outlier detection. See section 10.1.2.4. Case (Diagnostic) Statistics.
In Four-Parameter Logistic Model procedure, an option is introduced to compute the assay validity tests and fiducial confidence limits of estimated potency according to European Pharmacopoeia (1997-2017). See section 10.4.2.1. EP (European Pharmacopoeia).
A new specific assay procedure, Cylinder-Plate 5+1 Assay is added as described in United States Pharmacopoeia (2010) Chapter <81> Antibiotics-Microbial Assays. See section 10.6.1. Cylinder-Plate 5+1 Assay.