Pharmaceutical Stress Testing (eBook, PDF)

Predicting Drug Degradation, Second Edition
Redaktion: Baertschi, Steven W.; Reed, Robert A.; Alsante, Karen M.

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 624
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781439801802
• Artikelnr.: 56962584

Autorenporträt

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

Inhaltsangabe

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.