1st Edition

Statistical Design and Analysis in Pharmaceutical Science
Validation, Process Controls, and Stability

ISBN 9780367401870
Published June 19, 2019 by CRC Press
580 Pages

USD $74.95

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Book Description

"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."

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.

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Chow, Shein-Chung; Liu, Jen-pei