Pharmaceutical Dissolution Testing

ISBN-13: 9780824754679 / Angielski / Twarda / 2005 / 429 str.

Dressman; Jennifer Dressman; Johannes Kraemer

Opis

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.

Recenzje

"…an excellent handbook on methods of dissolution testing of pharmaceuticals….this book really does cover all aspects of dissolution testing, from the apparatus through development of methodology to the analysis and interpretation of results….

"…a really valuable contribution to the scientific literature. It contains some excellent chapters, and is a sound mixture of historical perspective, forward-looking science, and practiced-based dissolution methodology….recommend[ed]."
-European Journal of Pharmaceutics and Biopharmaceutics

"…the only up-to-date comprehensive book on dissolution testing. It would be a valuable reference for scientists involved in analytical testing or product development."
-Doody's Reviews

Spis treści

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

O autorze

Johannes Kramer, Jennifer J. Dressman