Statistical Design and Analysis of Pharmaceutical Sciences: Validation, Process Controls, and Stability / Edition 1

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1995 Hardback NEAR FINE This listing is a new book, a title currently in-print which we order directly and immediately from the publisher. Print on Demand title, produced to ... the highest standard, and there would be a delay in dispatch of around 15 working days. *****PLEASE NOTE: This item is shipping from an authorized seller in Europe. In the event that a return is necessary, you will be able to return your item within the US. To learn more about our European sellers and policies see the BookQuest FAQ section***** Read more Show Less

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Overview

"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."

The book contains black-and-white illustrations.

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Editorial Reviews

Publication of the International Statistical Institute
...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.
Technometrics
...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.
Booknews
A practical reference-text that provides a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development, emphasizing biopharmaceutical applications, demonstrating statistical techniques with real-world examples, and supplying Current Good Manufacturing Practice, US Food and Drug Administration, and International Conference on Harmonization guidelines on stability studies. Appendices provide statistical tables and SAS programs. Annotation c. Book News, Inc., Portland, OR (booknews.com)
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Product Details

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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