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.

• Richly illustrated and extensively referenced, this sourcedetails the execution and interpretation of small molecule stress testing studies
• Pprovides 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 interactionsexamines major mechanisms of degradation chemistry in the context of common functional groupsffers alternative approaches to the study of drug stability and degradation with computational approaches and microcalorimetry