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Pharmaceutical Dissolution Testing

Autor Jennifer B. Dressman, Johannes Kramer Editat de Jennifer J. Dressman
en Limba Engleză Hardback – 30 iun 2005
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.
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Specificații

ISBN-13: 9780824754679
ISBN-10: 0824754670
Pagini: 429
Ilustrații: 101 b/w images, 33 tables, 17 halftones and 46 equations
Dimensiuni: 161 x 237 x 25 mm
Greutate: 0.71 kg
Ediția:New.
Editura: CRC Press

Public țintă

Industrial, formulation, analytical, pharmaceutical, and quality control scientists; medicinal chemists; pharmacists; pharmacologists; toxicologists; biochemists; regulatory personnel; and graduate school students in these disciplines.

Cuprins

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