Statistical Design and Analysis of Stability Studies
"Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies." "After introducing the basic concepts of st...
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| Format: | Book |
| Language: | English |
| Published: |
New York
Chapman & Hall/CRC Taylor & Francis Group
2011
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| Series: | Chapman & Hall/CRC Biostatistics Series
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| Subjects: | |
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| Summary: | "Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies." "After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies." |
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| Physical Description: | xvii, 330 p. |
| ISBN: | 1584889055 |