Third Edition
edited by Jens T. Carstensen
and C. T. Rhodes

This newly revised and expanded, multiauthored reference/text 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.

The Third Edition describes the documentation required to minimize the chances of regulatory citations!

New Features:

• Lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications
• Highlights the International Conference of Harmonization (ICH) guidelines, noting possible deficiencies
• Focuses on requirements for pharmaceutical products containing chemical active ingredients intended for use by humans
• Discusses various causes of protein degradation and reveals methods of detection
• Emphasizes stability study objectives from the discovery phase through clinical formulations, readying drug products for marketing, and product revision following approval
• Covers the development and establishment of the industrial stability testing function
• And more!

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this reference is tailored for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; biostatisticians; toxicologists; analytical chemists; and quality control, quality assurance, and regulatory compliance managers; and is an ideal text for upper-level undergraduate and graduate students in these disciplines.

Contents

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 Stability Data
16. Stability of Polypeptides and Proteins
17. Regulatory Aspects of Stability Testing in Europe
18. Regulatory and Scientific Aspects of Stability Testing: Present and Possible Future Trends

Appendix

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