Abstract
Biological assay or bioassay is an analytical method used to measure the biological activity or potency of a biopharmaceutical or a vaccine. CMC statisticians contribute to the design, development, analysis and validation of bioassays. Skills in linear and nonlinear mixed effects modeling, design of experiments (DOE) and equivalence testing are essential to that support. This chapter describes statistical methods used to support bioassay and provides references for further explorations.
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Acknowledgements
I would like to thank Rick Burdick for his guidance in formulating confidence bounds on intermediate precision and format variability as well as his comments throughout the chapter. I would also like to thank Stan Altan for his careful review of the chapter and for his suggestions which added further clarity to some of the content.
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Schofield, T. (2016). Lifecycle Approach to Bioassay. In: Zhang, L. (eds) Nonclinical Statistics for Pharmaceutical and Biotechnology Industries. Statistics for Biology and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-23558-5_17
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DOI: https://doi.org/10.1007/978-3-319-23558-5_17
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-23557-8
Online ISBN: 978-3-319-23558-5
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