Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition

Steven W. Baertschi, Karen M. Alsante, Robert A. Reed

July 27, 2011 by CRC Press
Reference - 612 Pages - 423 B/W Illustrations
ISBN 9781439801796 - CAT# H100006
Series: Drugs and the Pharmaceutical Sciences

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Features

  • Details the execution and interpretation of small molecule stress testing studies
  • Provides a comprehensive overview of the major aspects of the prediction of drug degradation
  • Presents up-to-date approaches to pharmaceutical stress testing
  • Discusses the historical context and regulatory framework of stress testing
  • Critically addresses currently utilized methodologies and experimental designs
  • Addresses difficult problems such as mass balance, analytical limitations, and drug-excipient interactions
  • Examines major mechanisms of degradation chemistry in the context of common functional groups
  • Offers alternative approaches to the study of drug stability and degradation with computational approaches and microcalorimetry
  • Contains special coverage of freeze-drying processes
  • Provides quick reference to the problems frequently encountered by pharmaceutical researchers

Summary

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years.

Key features include:

  • A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience.
  • 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations
  • Updated methodologies for predicting drug stability and degradation pathways
  • Best practice models to follow
  • An expanded Frequently Asked Questions section

This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

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