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Statistical design and analysis of stability studies

By: Chow, Shein-Chung.
Material type: materialTypeLabelBookSeries: Chapman & Hall/CRC biostatistics series ; 19. Publisher: Boca Raton : Chapman & Hall/CRC, ©2007Description: xvii, 330 p. : ill. ; 25 cm.ISBN: 9781584889052.Subject(s): Drug stability | Drugs -- Research -- Statistical methods | Drug Stability | Research Design | Pharmaceutical Preparations -- standards | Statistics -- methodsOnline resources: Table of contents only
Contents:
Introduction -- 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.
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Includes bibliographical references (p. 307-322) and index.

Introduction -- 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.

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