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Statistical design and analysis of stability studies / Shein-Chung Chow.

By: Material type: TextTextSeries: Chapman & Hall/CRC biostatistics series ; 19Publication details: Boca Raton : Chapman & Hall/CRC, c2007.Description: xvii, 330 p. : ill. ; 25 cmISBN:
  • 9781584889052 (hardcover : alk. paper)
  • 1584889055 (hardcover : alk. paper)
Subject(s): LOC classification:
  • RS424 C11
NLM classification:
  • 2007 H-169
  • QV 754
Online resources:
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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