Biostatistics for Bioassay

<p>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. <b><i>Biostatistics for Bioassay</i></b> 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.</p><p><b>Features:</b></p><ul> <li>Explains the statistical methods needed at each stage of the lifecycle of a bioassay</li> <li>Describes the demonstration of the bioassay’s performance known as validation</li> <li>Covers the statistical techniques for monitoring the bioassay’s performance over time</li> <li>Details how to transfer the bioassay to another laboratory or replace critical reagents</li> <li>Provides examples at every stage to allow the reader to work through the techniques and consolidate their understanding</li> </ul><p>The 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.</p>