Module 9 2024

03/09/2024

Bioassays – life cycle IV

Research

Preclinical

Development

Clinical

Evaluation

Phases

Qualification

1

The Organisation for Professionals in Regulatory Affairs

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Assay design & stats analysis

Statistical methods used for analysis of assays are typically based on these assumptions: • The data is normally distributed

• The groups that are being compared have similar variance

• The data is independent

The Organisation for Professionals in Regulatory Affairs

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