Browsing by Author "Cann, Liam"

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    Statistical analysis of bioassay data with dependent replicates
    (University of New Brunswick, 2025-03) Cann, Liam; Stewart, Connie; Stephenson, Matthew
    Bioassays play a key role in ensuring that every batch of drug produced is safe and effective for release. They play a critical role in testing the potency of biologic drugs, such as vaccines or monoclonal antibodies. Due to the importance of bioassays in ensuring a safe and effective product, it is critical that the statistical methods used are appropriate. However, it is the current common practice to treat the replicate responses at each dose group as if they are independent despite the fact they are often correlated. In this research, we look at quantitatively assessing the risks of the conventional analysis methods using a simulation study to investigate the impact of correlation on the statistical analysis of bioassays. Specifically, we consider parallelism assessment, model goodness-of-fit, and relative potency estimation. We also make recommendations within the constraints of the current available commercial bioassay analysis software to provide valid statistical inference.