validation, process controls, and stability
Edición de la obra Statistical design and analysis in pharmaceutical science
| Autor | Shein-Chung Chow |
|---|---|
| Editorial | M. Dekker |
| Fecha de publicación | 1995 |
| Lugar | New York |
| Idioma | inglés |
| Páginas | 564 |
| ISBN-10 | 0824793366 |
| OCLC | 1047532528, 44955014, 31604915 |
| LCCN | 94043570 |
| Serie | Statistics, textbooks and monographs ; · v. 143 |
| Número de Cutter |
C552s |
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.