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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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Bibliographic Details
Main Author: Chow, Shein-Chung, 1955- (Author)
Format: Book
Language:English
Published: Boca Raton, FL Chapman & Hall/CRC 2007.
Series:Chapman & Hall/CRC biostatistics series 19
Subjects:
Drug Stability.
Research Design.
Pharmaceutical Preparations > standards.
Statistics as Topic > methods.
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Table of Contents:
  • 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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