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

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Paperback: 9780367401870
pub: 2019-06-19
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Hardback: 9780824793364
pub: 1995-02-22
$145.00
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eBook (VitalSource) : 9781315274294
pub: 2018-10-03
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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.

About the Authors

Chow, Shein-Chung; Liu, Jen-pei

Subject Categories

BISAC Subject Codes/Headings:
MAT029000
MATHEMATICS / Probability & Statistics / General
MED071000
MEDICAL / Pharmacology