Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition

ISBN-13: 9781439801796 / Angielski / Twarda / 2011 / 612 str.

Baertschi

Opis

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.

Spis treści

Introduction. Stress Testing: A Predictive Tool. The Chemistry of Drug Degradation. Stress Testing: Analytical Considerations. Relation to the Development Timeline. Oxidative Susceptibility Testing . Photostability Stress Testing. Practical Aspects of Conducting Photostability Stress Testing. Role of 'Mass Balance' in Pharmaceutical Stress Testing. Solid-State Pharmaceutical Development: Ensuring Stability Through Salt and Polymorph Screening. Solid-State Excipient Compatibility Testing.Small Molecule Parenteral Drugs: Practical Aspects of Stress Testing. Stability Considerations in Development of Freeze Dried Pharmaceuticals. Stress Testing of Therapeutic Monoclonal Antibodies. Stress Testing of Oligonucleotides. Stress Testing to Determine Liposome Degradation Mechanisms. Stress Testing of Combination Therapies. Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes or Materials from Multiple Sources. Stress testing as a predictive tool for the assessment of potential genotoxic degradants. The Power of Computational Chemistry to Leverage Stress Testing of Pharmaceuticals. Use of Automation in Conducting Stress Testing and Excipient Compatibility Studies. The Use of Microcalorimetry in Stress Testing. Stress Testing as it Relates to Shipping / Distribution - Real World Measurements and Implications. Stress Testing: Frequently Asked Questions.

O autorze

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