Module 9 2024

03/09/2024

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, specificity and stability indicating measurements. • New technologies maybe time heavy initially but can save time later down the line so should be considered.

The Organisation for Professionals in Regulatory Affairs

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Questions ??

Contact details: paula.urquhart@labcorp.com

The Organisation for Professionals in Regulatory Affairs

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