Module 9 2021

24/03/2021

Bioassay Summary

• Bioassays assess activity of a product • Bioassay systems are highly complex and subject to many sources of variability • Absolute measures of activity vary between assays so potency is measured relative to a reference standard • Assay design must be appropriate to the statistical analysis used and include factors such as replication and randomisation • Validation of an assay must include determinations of accuracy, precision, range and linearity and specificity measurements.

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The Organisation for Professionals in Regulatory Affairs

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