Statistical Theory And Analysis In Bioassay

STATISTICAL THEORY AND ANALYSIS IN BIOASSAY

Statistical Theory and Analysis in Bioassay is a seven chapter monograph tailored essentially to meet the needs of graduate students, practitioners and researchers in the fields of medicine, pharmacology, biosciences/life sciences and related fields that employs the tools of biostatistics in bioassays and analysis. In this wise, we have taken time to discuss in details relevant topics; principles, methods and applications. Practice exercises are also included where necessary. The earlier chapters give background information, definition of terms, purpose, types, structure and relative potency in bioassay. An important theorem, Fieller’s theorem is proved in details with illustrative examples. The last two chapters are on dose-response relationship, fitting in parallelline assays and estimation. We are convinced that this monograph will meet the expectations of the readers while constructive criticisms that will improve another edition will be appreciated.

Biostatistics for Bioassay

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 bioassay Describes the demonstration of the bioassay’s performance, known as validation Covers the statistical techniques for monitoring the bioassay’s performance over time Details how to transfer the bioassay to another laboratory or replace critical reagents Provides examples at every stage, to allow the reader to work through the techniques and consolidate their understanding 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.

JNCI, Journal of the National Cancer Institute