In Version 10 new procedures and improvements are mainly in Analysis of Bioassays module. Unistat's Bioassay module is now the most comprehensive and the best off-the-shelf software program for Bioassay analysis.
The specific audience for the Unistat Bioassay module are the biomedical researchers within pharmaceutical production plants and their QC departments. Few of those researchers are involved with the European quality standards for Pharmacopoeial standards which contribute to delivering high quality medicines in Europe and beyond. Their work are according the topic of "Statistical Analysis of Bioassays according to European Pharmacopoeia and Unistat States Pharmacopoeia".
Unistat is now very strong in bioassay analysis.
|Product:||LIGHT Edition||STANDARD Edition|
|Single-user license||€ 200||€ 975|
|Additional license||€ 180||€ 400|
(including the Standard Edition)
See for more information on the Light Edition and : https://www.unistat.com/products/unistat-light/
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.
A new Graphics size control is added to Tools → Options dialogue’s Output tab to change the graphics metafile size in output. See section 188.8.131.52.5. Graphics Size.
In cases where effectivity of a drug or a substance cannot be assessed by chemical or physical analysis, it can be assessed by testing its effects on biological organisms. Such experiments are called biological assays, or bioassays in short. The most common form of bioassay is where the potency of one or more test preparations is determined by comparison to a standard preparation.
With Version 10, Unistat's optional Analysis of Bioassays module becomes probably the most powerful software tool in its sector.
1. Compliance: A comprehensive set of tools has been introduced to ensure compliance with FDA 21 CFR Part 11 requirements. https://www.unistat.com/guide/bioassay-analysis-overview/#u1005
2. 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. https://www.unistat.com/guide/bioassay-analysis-overview/#u1004
3. 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. https://www.unistat.com/guide/bioassay-analysis-overview/#u1002
4. 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. https://www.unistat.com/guide/bioassay-analysis-overview/#u1006
5. 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. https://www.unistat.com/guide/bioassay-analysis-cylinder-plate-5-1-assay/
6. 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. https://www.unistat.com/guide/bioassay-analysis-parallel-line-method/#u10121
7. Case (Diagnostic) Statistics: Facilitating reporting of estimated and predicted values, standardised residuals and model-based outlier detection. https://www.unistat.com/guide/bioassay-analysis-parallel-line-method/#u10124
8. Bioassay module The full list of procedures available under the Bioassay module is as follows:
Parallel Line Method
- Completely Randomised Design
- Randomised Block Design
- Latin Squares Design
- Crossover Design
Slope Ratio Method
- Plate Effects
Quantal Response Method
Four-Parameter Logistic Model
- European Pharmacopoeia (EP)
- Full Model (USP)
- Reduced Model (USP)
Combination of Assays
Cylinder-Plate (5+1) Assay
You can download and try Unistat 10 using the data sets provided with the package.
Please note that Analysis of Bioassays is an optional module. It is separately priced and requires a Standard Edition license to run.
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