In recent decades, there has been enormous growth in biologics research and development, with the accompanying development of biological assays for emerging products. In parallel, there have been substantial advances in statistical methodology, as well as technological advances in computer power, enabling new techniques to be implemented via statistical software. Biostatistics for Bioassay presents an overview of 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. Beginning with consideration of the performance characteristics required of a bioassay, including accuracy, precision, and combinations of these two attributes, the book builds a framework for statistical bioassay design.Features:Explains the statistical methods needed at each stage of the lifecycle of a bioassayDescribes the demonstration of the bioassay’s performance, known as validationCovers the statistical techniques for monitoring the bioassay’s performance over timeDetails how to transfer the bioassay to another laboratory or replace critical reagentsProvides examples at every stage, to allow the reader to work through the techniques and consolidate their understandingThe book provides a resource for interested bioassay analysts, and statisticians working with bioassays. In bringing together best practices in statistics across the bioassay lifecycle into a single volume, it aims to provide a comprehensive and useful textbook for statistical analysis in bioassay.
