Statistical design and analysis of stability studies
Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing. It focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods.
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| Main Author: | |
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| Format: | Book |
| Language: | English |
| Published: |
Boca Raton, FL
Chapman & Hall/CRC
2007.
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| Series: | Chapman & Hall/CRC biostatistics series
19 |
| Subjects: | |
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| 020 | |a 9781584889052 (hbk) | ||
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| 100 | 1 | |a Chow, Shein-Chung, |d 1955- |e author | |
| 245 | 1 | 0 | |a Statistical design and analysis of stability studies |c Shein-Chung Chow. |
| 264 | 1 | |a Boca Raton, FL |b Chapman & Hall/CRC |c 2007. | |
| 264 | 4 | |c ©2007 | |
| 300 | |a xvii, 330 pages |b illustrations |c 25 cm. | ||
| 336 | |a text |2 rdacontent | ||
| 337 | |a unmediated |2 rdamedia | ||
| 338 | |a volume |2 rdacarrier | ||
| 490 | 1 | |a Chapman & Hall/CRC biostatistics series |v 19 | |
| 504 | |a Includes bibliographical references (p. 307-322) and index. | ||
| 505 | 0 | |a Accelerated testing -- Expiration dating period -- Stability designs -- Stability analysis with fixed batches -- Stability analysis with random batches -- Stability analysis with a mixed effects model -- Stability analysis with discrete responses -- Stability analysis with multiple components -- Stability analysis with frozen drug products -- Stability testing for dissolution -- Current issues and recent development. | |
| 520 | |a Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing. It focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods. | ||
| 592 | |a 1041 |b 8/11/2019 |c RM278.20 |h Amwood | ||
| 650 | 1 | 2 | |a Drug Stability. |
| 650 | 1 | 2 | |a Research Design. |
| 650 | 2 | 2 | |a Pharmaceutical Preparations |x standards. |
| 650 | 2 | 2 | |a Statistics as Topic |x methods. |
| 830 | 0 | |a Chapman & Hall/CRC biostatistics series |v 19 | |
| 999 | |a vtls000044487 |c 55087 |d 55087 | ||