Bioassay Analysis

UNISTAT’s optional Analysis of Bioassays module is a comprehensive implementation of United States Pharmacopoeia chapters <111>, <1033>, <1034> and <81> (2010) and European Pharmacopoeia (1997-2017) Statistical Analysis of Results of Biological Assays and Tests. It is also validated against Finney, D. J. (1978), Statistical Method in Biological Assay and is ready for use in a regulated environment. UNISTAT’s bioassay methods are widely used for biological research and drug development.

Statistical analysis of data from biological dilution assays or potency assays: Potency calculations can be performed employing parallel line, slope ratio, quantal response or four-parameter logistic model, complete with fiducial confidence intervals, validity tests, potency, ED50, Spearman-Karber method and graphical representations.

The optional Analysis of Bioassays module requires UNISTAT Standard Edition to run. Please contact Unistat Ltd for a quotation.

• Parallel Line Assay: Completely Randomised Design, Randomised Block Design, Latin Squares Design, Crossover Design
• Slope Ratio Assay: Blanks, Plate Effects
• Quantal Response Assay: Logit, Probit, Gompit, Loglog link functions
• Four-Parameter Logistic Model: European Pharmacopoeia (EP), Full Model (USP), Reduced Model (USP)
• Combination of Assays: EP, USP
• Cylinder-Plate (5+1) Assay

Major new features in Version 10 include:

1. Compliance: A comprehensive set of tools has been introduced to ensure compliance with FDA 21 CFR Part 11 requirements.
2. IQ OQ PQ Package (IQ/OQ/PQ, IQ-OQ-PQ, IQOQPQ): This is available from Unistat Ltd upon request. It contains a detailed Installation Qualification (IQ) for Administrators and Standard Users, an Operational Qualification (OQ) featuring a validation of Unistat’s numeric accuracy and a fully automated target installation verification and Performance Qualification (PQ) tools enabling the customer to compile PQ documents with ease.
3. Multiple Assays with Combination: It is possible to run multiple assays and combine their results (using USP and/or EP methods) with a single click, in all bioassay methods.
4. Potency Calculations: Given all assigned and assumed potencies, pre-dilutions, reconstitutions, unit transformations, volume administrations, conversions and inoculations a final potency value can be calculated and displayed in the final report.
5. Outlier Detection, Omission and Replacement: Outliers can be detected (a) in data (i.e. in treatment groups) using Dixon, Grubbs and ESD methods and (b) based on model fit using standardised residuals. Outliers can be omitted or replaced automatically or manually.
6. Cylinder-Plate (5+1) Assay: This new specific assay procedure is now available as described in United States Pharmacopoeia (2010) Chapter <81> Antibiotics-Microbial Assays.
7. Validity of Data: Available output options are Summary Statistics, Normality Tests, Homogeneity of Variance Tests, Outlier Tests, Box-Whisker, Dot and Bar Plots and Normality Plots.
8. Case (Diagnostic) Statistics: Facilitating reporting of estimated dose and response values, predictions, interpolations, standardised residuals and model-based outlier detection.