Biostatistics for Bioassay

This book is about the statistical analysis techniques that are needed in order to report the results of biological assays. These assays are needed for testing all biological medicines, such as vaccines and cell therapies, to allow them to be released for use.

List of contents

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.

About the author

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.

Summary

This book is about the statistical analysis techniques that are needed in order to report the results of biological assays. These assays are needed for testing all biological medicines, such as vaccines and cell therapies, to allow them to be released for use.

Product details

• Authors: Matthew Stephenson, Stephenson Matthew, Ann Yellowlees, Ann Stephenson Yellowlees
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 24.12.2024
• EAN: 9781032579726
• ISBN: 978-1-0-3257972-6
• No. of pages: 296
• Series: Chapman & Hall/CRC Biostatistics Series
• Subjects: Natural sciences, medicine, IT, technology > Mathematics > Probability theory, stochastic theory, mathematical statistics; Epidemiology & medical statistics, MATHEMATICS / Probability & Statistics / General, SCIENCE / Chemistry / Analytic, MEDICAL / Biostatistics, Biology, life sciences, Probability & statistics, Pharmaceutical technology, Analytical Chemistry, Probability and statistics, Epidemiology and Medical statistics, Pharmaceutical chemistry and technology, potency;biotech;drug development