Module 9 2021

24/03/2021

Bioassay Validation

Results • Different concentrations of analyte are tested to show precision and accuracy at different target potency levels. • Target potency levels: 50%, 71%, 100%, 141%, 200% are often tested. Log values measured – equally spaced on the x axis. Precision, range and lineary Accuracy

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Bioassay life cycle V

Research

Preclinical

Development

Clinical Phases

Evaluation Qualification Validation

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Post-filing

Continued monitoring & trending

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