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

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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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Author(s)

Biography

Chow, Shein-Chung; Liu, Jen-pei