Drug Stability, Revised, and Expanded

Principles and Practices

AvJens T. Carstensen,Christopher Rhodes

Inbunden, Engelska, 2000

Del i serien Drugs and the Pharmaceutical Sciences

2 147 kr

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Beskrivning

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.

Produktinformation

Utgivningsdatum:2000-07-28
Mått:174 x 246 x 47 mm
Vikt:1 630 g
Format:Inbunden
Språk:Engelska
Serie:Drugs and the Pharmaceutical Sciences
Antal sidor:792
Upplaga:3
Förlag:Taylor & Francis Inc
ISBN:9780824703769

Utforska kategorier

Farmakologi inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik

Mer om författaren

Jens T. Carstensen, Madison, Wisconsin. C. T. Rhodes, University of Rhode Island Kingston, Rhode Island.

Innehållsförteckning

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