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Pharmaceutical Dissolution Testing
Langbeschreibung
An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.
Inhaltsverzeichnis
Historical Development of Dissolution Testing. Compendial Testing Equipment: Calibration, Qualification, and Sources of Error. Compendial Requirements of Dissolution Testing. The Role of Dissolution Testing in the Regulation of Pharmaceuticals: The FDA Perspective. Physiological Parameters Relevant to Dissolution Testing: Composition of Fluids in the GI Tract. Physiological Parameters Relevant to Dissolution Testing: Hydrodynamic Considerations. Physiological Parameters Relevant to Dissolution Testing: Behavior of Solid Pharmaceuticals in the GI Tract. Dissolution Data Analysis with a View to IVIVC. Analysis and Interpretation of Time Profiles In Vitro and In Vivo. Pharmacokinetic Study Design with a View to Quality Control. Dissolution Method Development: An Industrial Perspective. Design and Qualification of Automated Dissolution Systems
Johannes Kramer, Jennifer J. Dressman
ISBN-13:
9780849359170
Veröffentl:
2005
Seiten:
429
Autor:
Jennifer J. Dressman
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
2 - DRM Adobe
Sprache:
Englisch
233,99 €*
Lieferzeit: Sofort lieferbar
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