Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition, 2nd Edition (Hardback) book cover

Pharmaceutical Stress Testing

Predicting Drug Degradation, Second Edition, 2nd Edition

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

CRC Press

612 pages | 423 B/W Illus.

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pub: 2011-07-27
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Description

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).

Reviews

"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

Table of Contents

Introduction

Steven W. Baertschi and Dan W. Reynolds

Stress Testing: A Predictive Tool

Steven W. Baertschi, Patrick J. Jansen, K.M. Alsante, Dan Reynolds and Biren Joshi

The Chemistry of Drug Degradation

Steven W. Baertschi, Karen M. Alsante and Dinos Santifianos

Stress Testing: Analytical Considerations

Patrick J. Jansen, W. Kimmer Smith, and Steven W. Baertschi

Relation to the Development Timeline

Steven W. Baertschi, Bernard A. Olsen, Karen M. Alsante and Robert A. Reed.

Oxidative Susceptibility Testing

Paul Harmon and Giovanni Boccardi

Photostability Stress Testing

Elisa Fasani and Angelo Albini

Practical Aspects of Conducting Photostability Stress Testing

David Clapham, Allen Templeton, Lee J. Klein, and Mark H. Kleinman

Role of 'Mass Balance' in Pharmaceutical Stress Testing

Mark A. Nussbaum, Patrick J. Jansen, Steven W. Baertschi, Andreas Kaerner, and Bernard A. Olsen.

Solid-State Pharmaceutical Development: Ensuring Stability Through Salt and Polymorph Screening

Gregory A. Stephenson and Susan Reutzel-Edens

Solid-State Excipient Compatibility Testing

Amy S. Antipas, Margaret S. Landis, and Peter Wuelfing

Small Molecule Parenteral Drugs: Practical Aspects of Stress Testing

Andreas Abend, Brett Duersch, and Kyle Fiszlar

Stability Considerations in Development of Freeze Dried Pharmaceuticals

Steven L. Nail

Stress Testing of Therapeutic Monoclonal Antibodies

Michael R. DeFelippis, Bryan J. Harmon, Lihua Huang, and Muppalla Sukumar

Stress Testing of Oligonucleotides

Daniel Capaldi

Stress Testing to Determine Liposome Degradation Mechanisms

Patrick Ahl and Paul Meers

Stress Testing of Combination Therapies

Dan Reynolds and Biren Joshi

Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes or Materials from Multiple Sources

Bernard A. Olsen, Larry A. Larew, and Michael A. Watkins

Stress testing as a predictive tool for the assessment of potential genotoxic degradants

Christopher M. Riley, Dan Reynolds, Alan McKeown, Joel Bercu, Dave DeAntonis, Steve Baertschi, and Stephen Raillard

The Power of Computational Chemistry to Leverage Stress Testing of Pharmaceuticals

Thomas R. Sharp and Donald B. Boyd

Use of Automation in Conducting Stress Testing and Excipient Compatibility Studies

Chris Foti, Patrick Jansen, Eric Carlson

The Use of Microcalorimetry in Stress Testing

Graham Buckton and Simon Gaisford

Stress Testing as it Relates to Shipping / Distribution - Real World Measurements and Implications

Manuel Zahn

Stress Testing: Frequently Asked Questions

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

About the Series

Drugs and the Pharmaceutical Sciences

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General