Covering in detail validation, quality assurance, and stability studies, Statistical Design and Analysis in Pharmaceutical Science furnishes definitions, background information, and regulatory requirements . . . addresses statistical designs and methods for assay development and validation . . . delineates specification limits and United States Pharmacopeia tests for various dosage forms . . . elucidates validation of manufacturing processes, including prospective, concurrent, and retrospective validation and revalidation . . . examines chemical kinetic models used in accelerated stability testing, statistical analysis, and prediction through the Arrhenius equation . . . compares stability designs and introduces statistical analysis of stability data based on fixed effect models . . . and much more.

This practical reference/text offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development - emphasizing biopharmaceutical applications, demonstrating statistical techniques with real-world examples, and supplying Current Good Manufacturing Practice (CGMP), U.S. Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) guidelines on stability studies.