Drug Stability, Revised, and Expanded
Principles and Practices
3rd Edition
Published on 28. July 2000
Book
Hardback
792 pages
978-0-8247-0376-9 (ISBN)
Description
Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.
More details
Series
Edition
3rd edition
Language
English
Place of publication
Bosa Roca
United States
Publishing group
Taylor & Francis Inc
Target group
College/higher education
Professional and scholarly
Academic and Professional Practice & Development
Dimensions
Height: 246 mm
Width: 174 mm
Weight
1630 gr
ISBN-13
978-0-8247-0376-9 (9780824703769)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Persons
Jens T. Carstensen, Madison, Wisconsin. C. T. Rhodes, University of Rhode Island Kingston, Rhode Island.
Content
Preface 1. Introductory Overview 2. Solution Kinetics 3. Kinetic pH Profiles 4. Oxidation in Solution 5. Catalysis, Complexation, and Photolysis 6. Solid State Stability 7. Interactions of Moisture with Solids 8. Physical Characteristics of Solids 9. Preformulation 10. Physical Testing 11. Development and Validation of HPLC Stability-Indicating Assays 12. Stability Testing of Clinical Trial Materials 13. A Rational Approach to Stability Testing and Analytical Development for NCE, Drug Substance, and Drug Products: Marketed Product Stability Testing 14. Packaging, Package Evaluation, Stability, and Shelf-Life 15. Industrial Stability Testing in the United States and Computerization of Stabililty Data 16. Stability of Polypeptides and Proteins17. Regulatory Aspects of Stability Testing in Europe 18. Regulatory and Scientific Aspects of Stability Testing: Present and Possible Future Trends