Pharmaceutical Dissolution Testing

by Jennifer J. Dressman (Editor), Johannes Kramer (Editor)

Overview

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

Product Details

ISBN-13:	9781040175040
Publisher:	CRC Press
Publication date:	07/08/2005
Sold by:	Barnes & Noble
Format:	eBook
Pages:	429
File size:	7 MB

About the Author

Johannes Kramer, Jennifer J. Dressman

Table of Contents

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

Editorial Reviews

"…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

From the Publisher