I Potency and its measurement: bioassays and their performance
1. Introduction - bioassays and potency
2. Bioassay performance requirements
3. Bioassay design
II Estimation of potency: the statistical analysis of bioassay runs
4. Statistical models for characterising the dose-response relationship
5. Choosing the dose-response relationship for bioassay data
6. Assay data analysis
7. Bioassay suitability criteria
III Validation, monitoring and modifications
8. Qualification and validation of bioassays
9. Monitoring the performance of a bioassay procedure
10.Bioassay updates and modifications
Biography
Ann Yellowlees is Founder of Quantics Biostatistics. Ann has worked in academia, Shell Research, and the NHS in Scotland. She has been consulting in bioassay statistics since 2006. She holds degrees in both mathematics and applied statistics from the University of Oxford, and a PhD in statistics from the University of Waterloo.
Matthew Stephenson is a Director of Statistics at Quantics Biostatistics, with an undergraduate degree in human kinetics, and an MSc and PhD in statistics from the University of Guelph. He won the 2020 Canadian Journal of Statistics Award for his PhD research on leveraging graphical structure among predictors to improve outcome prediction.
