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Statistical design and analysis in pharmaceutical science: validation, process controls, and stability

Contributor(s): Material type: TextTextSeries: Statistics, Textbooks and Monographs - Vol.143Publication details: New York Marcel Dekker 1995Description: viii, 564 pISBN:
  • 9780824793364
Subject(s): DDC classification:
  • 615.1072 S8
Summary: 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. 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. Table of content: 1. Introduction 2. Assay Development 3. Assay Validation 4. Scaleup Design and Analysis 5. USP Tests and Specifications 6. Process Validation 7. Quality Assurance 8. Stability Studies 9. Accelerated Testing 10. Design for Long-Term Stability Studies 11. Stability Analysis with Fixed Batches 12. Stability Analysis with Random Batches (https://openlibrary.org/works/OL2697979W/Statistical_design_and_analysis_in_pharmaceutical_science)
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Item type Current library Item location Collection Shelving location Call number Status Date due Barcode
Books Vikram Sarabhai Library Rack 33-B / Slot 1737 (2nd Floor, East Wing) Non-fiction General Stacks 615.1072 S8 (Browse shelf(Opens below)) Available 189680

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.
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.

Table of content:
1. Introduction
2. Assay Development
3. Assay Validation
4. Scaleup Design and Analysis
5. USP Tests and Specifications
6. Process Validation
7. Quality Assurance
8. Stability Studies
9. Accelerated Testing
10. Design for Long-Term Stability Studies
11. Stability Analysis with Fixed Batches
12. Stability Analysis with Random Batches
(https://openlibrary.org/works/OL2697979W/Statistical_design_and_analysis_in_pharmaceutical_science)

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