Statistical design and analysis of stability studies
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Boca Raton
Name of Publisher, Distributor, etc.
Chapman & Hall/CRC,
Date of Publication, Distribution, etc.
c2007
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xvii, 330 p. ill.
SERIES
Series Title
Chapman & Hall/CRC biostatistics series ;19
NOTES PERTAINING TO BINDING AND AVAILABILITY
Text of Note
مرجع به حساب نمي آيد
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references (p. 307-322) and index.
Text of Note
ng
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.