Pharmaceutical Stress Testing: Predicting Drug Degradation, Second Edition (Drugs and the Pharmaceutical Sciences)
ISBN 10: 1439801797 ISBN 13: 9781439801796
Published by CRC Press, 2011
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Hardcover
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Bay State Book Company, North Smithfield, RI, U.S.A.
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About this Item
Description:
The book is complete and readable, with all pages and cover intact. Dust jacket, shrink wrap, or boxed set case may be missing. Pages may have light notes, highlighting, or minor water exposure, but nothing that affects readability. May be an ex-library copy and could include library markings or stickers. Seller Inventory # BSM.U2T4
Synopsis:
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).
About the Author: Steven W. Baertschi, Karen M. Alsante, Robert A. Reed
"About this title" may belong to another edition of this title.
Bibliographic Details
Title: Pharmaceutical Stress Testing: Predicting ...
Publisher: CRC Press
Publication Date: 2011
Binding: Hardcover
Condition: acceptable
Edition: 2nd Edition