Author Description

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.