Pharmaceutical Stress Testing by Baertschi, Steven W.; Alsante, Karen M.; Reed, Robert A.;

Rövid leírás:

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 fro

Hosszú leírás:

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).

"The authors and editor have done a superb job of combining the theoretical, chemical, and practical aspects of stress testing…the text is a 'must have' for those involved in stability testing."
—Drug Development and Industrial Pharmacy

"This excellent reference on pharmaceutical stress testing will serve its purpose well, especially for pharmaceutical product development scientists and for members of regulatory agencies who are actively involved in the drug review and approval process."
—Doody's Review Service

Tartalomjegyzék:

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.