Richly illustrated and extensively referenced, this source:

• 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

The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.

Contents

• Stress Testing: A Predictive Tool
• Stress Testing: Relation to the Development Timeline
• Stress Testing: Frequently Asked Questions
• Stress Testing: Analytical Considerations
• Oxidative Susceptibility Testing
• Photostability Stress Testing
• Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes of Materials from Multiple Sources
• The Chemistry of Drug Degradation
• The Role of "Mass Balance" in Pharmaceutical Stress Testing
• Physical and Chemical Stability Considerations in the Development and Stress Testing of Freeze-Dried Pharmaceuticals
• Excipient Compatibility Studies

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