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

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"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.
...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.
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 (
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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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