Statistical Design and Analysis in Pharmaceutical Science
Validation, Process Controls, and Stability
1st Edition
Published on 3. October 2018
580 pages
978-1-351-99074-5 (ISBN)
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."
Reviews / Votes
". . .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. "
---Technometrics
More details
Edition
1. Auflage
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
Professional and scholarly
Product notice
Reflowable
ISBN-13
978-1-351-99074-5 (9781351990745)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Shein-Chung Chow | Jen-pei Liu
Statistical Design and Analysis in Pharmaceutical Science
Validation, Process Controls, and Stability
Book
06/2019
1st Edition
CRC Press
€98.00
Shipment within 15-20 days
Shein-Chung Chow | Jen-pei Liu
Statistical Design and Analysis in Pharmaceutical Science
Validation, Process Controls, and Stability
Book
02/1995
1st Edition
CRC Press
€179.51
Shipment within 15-20 days
Persons
Chow, Shein-Chung; Liu, Jen-pei
Content
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.
