Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability, 1st Edition (Hardback) book cover

Statistical Design and Analysis in Pharmaceutical Science

Validation, Process Controls, and Stability, 1st Edition

By Shein-Chung Chow, Jen-pei Liu

CRC Press

580 pages

Purchasing Options:$ = USD
Hardback: 9780824793364
pub: 1995-02-22
eBook (VitalSource) : 9781482273137
pub: 1995-02-22
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"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."


". . .comprehensive. . ..a useful reference for practitioners as well as a good source for statisticians wishing to understand some of the key issues in these aspects of drug development. "

---Publication of the International Statistical Institute

". . .Particularly appealing in this book are the extensive explanations of technical concepts, beginning with a fine overview. . .and continuing as concepts such as assay validation, process validation, quality assurance, and stability studies are introduced subsequently. "


Table of Contents

Assay development; assay validation; scaleup design and analysis; USP tests and specifications; process validation; quality assurance; stability studies; accelerated testing; design for long-term stability studies; stability analysis with fixed batches; stability analysis with random batches. Appendices: statistical tables; SAS programs; regulations. references.

About the Series

Statistics: A Series of Textbooks and Monographs

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Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology