Module 9 2021

24/03/2021

Bioassay Validation

Robustness

• Deliberate variations in the method parameters assessed: Incubation times, different analysts, different instruments (plate readers

• Ideally the assay is not influenced by these different factors = robust assay.

The Organisation for Professionals in Regulatory Affairs

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Bioassay Validation

ICH 5QC Stability indicating

“Potency studies should be performed at appropriate intervals as defined in the stability protocol and the results should be reported in units of biological activity calibrated, whenever possible, against nationally or internationally recognised standard. Where no national or international standards exists, the assay results may be reported in in-house derived units using a characterised reference material”

The Organisation for Professionals in Regulatory Affairs

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