Bioassay Analysis using Unistat

UNISTAT's optional Analysis of Bioassays module is probably the most comprehensive implementation of the subject in any statistical software package. It is based on Finney, D. J. (1978), Statistical Method in Biological Assay, and conforms fully to the specification given in European Pharmacopoeia 7th Edition, (2011) Statistical Analysis of Results of Biological Assays and Tests.

Statistical analysis of data from biological dilution assays or potency assays: Potency calculations can be performed employing parallel line, slope ratio and quantal response methods, complete with fiducial confidence intervals, validity tests and graphical representations.

The Analysis of Bioassays module is validated against many examples provided in the above publications and it is ready for use in a regulated environment. UNISTAT's bioassay methods are widely used for biological standardization in natural product research and drug development.

Other types of bioassays and effective dose (or ED50) applications can be analysed using UNISTAT's nonlinear and logit / probit / gompit regression procedures.

The optional Analysis of Bioassays module requires UNISTAT Standard Edition to run.

• Parallel Line Assay
• Slope Ratio Assay
• Quantal Response Assay with logit / probit / gompit models
• Combination of Assays
• validity tests, potency, fiducial limits, ED50.
• Fully validated with European Pharmacopoeia 7th edition (2011) and Finney (1978).