Statistical design and analysis in pharmaceutical science
Subtitle: validation, process controls, and stability
By: edited by Shein-Chung Chow, Jen-pei Liu.
Contributors: Liu, Jen-pei, 1952-
Series: Statistics, textbooks and monographs ;; v. 143
Publisher: M. Dekker
Published: 1995
Place of publication: New York
Language: eng
Number of pages: 564
Subjects: Pharmacy -- Statistical methods.; Drugs -- standards.; Chemistry, Pharmaceutical -- methods.; Statistics.
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.
Notes: Includes bibliographical references (p. 549-555) and index.
Evidence in the book indicates that Shein-Chung Chow and Jen-pei Liu are authors, not editors.