Statistical design and analysis of stability studies /
General Material Designation
[Book]
First Statement of Responsibility
Shein-Chung Chow
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xvii, 330 pages :
Other Physical Details
illustrations ;
Dimensions
25 cm
SERIES
Series Title
Chapman & Hall/CRC biostatistics series ;
Volume Designation
19
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references (pages 307-322) and index
CONTENTS NOTE
Text of Note
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