Cover image for Drug stability : principles and practices
Title:
Drug stability : principles and practices
Author:
Carstensen, Jens Thur,̜ 1926- editor.
ISBN:
9781420029871
Edition:
Third edition, revised and expanded.
Physical Description:
1 online resource : text file, PDF
Series:
Drugs and the pharmaceutical sciences ; 107
Series Title:
Drugs and the pharmaceutical sciences ; 107
Contents:
1. Introductory overview / C. T. Rhodes -- 2. Solution kinetics / Jens T. Carstensen -- 3. Kinetic pH profiles / Jens T. Carstensen -- 4. Oxidation in solution / Jens T. Carstensen -- 5. Catalysis, complexation, and photolysis / Jens T. Carstensen -- 6. Solid state stability / Jens T. Carstensen -- 7. Interactions of moisture with solids / Jens T. Carstensen -- 8. Physical characteristics of solids / Jens T. Carstensen -- 9. Preformulation / Jens T. Carstensen -- 10. Physical testing / Jens T. Carstensen -- 11. Development and validation of HPLC stability-indicating assays / Donald D. Hong and Mumtaz Shah -- 12. Stability testing of clinical trial materials / Wolfgang Grimm -- 13. A rational approach to stability testing and analytical development for NCE, drug substance, and drug products : marketed product stability testing / Wolfgang Grimm -- 14. Packaging, package evaluation, stability, and shelf-life / D. A. Dean -- 15. Industrial stability testing in the United States and computerization of stabililty data / Shri C. Valvani -- 16. Stability of polypeptides and proteins / Mary D. DiBiase and Mary K. Kottke -- 17. Regulatory aspects of stability testing in Europe / Brian R. Matthews -- 18. Regulatory and scientific aspects of stability testing : present and possible future trends / C. T. Rhodes.
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