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Pharmaceutical dissolution testing

Author: J B Dressman; Johannes Krämer
Publisher: Boca Raton : Taylor & Francis, 2005.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:
"A 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  Read more...
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Document Type: Book
All Authors / Contributors: J B Dressman; Johannes Krämer
ISBN: 0824754670 9780824754679
OCLC Number: 60605304
Description: xv, 429 pages : illustrations ; 24 cm
Contents: 1. Historical development of dissolution testing / Johannes Krämer, Lee Timothy Grady and Jayachandar Gajendran --
2. Compendial testing equipment: calibration, qualification and sources of error / Vivian A. Gray --
3. Compendial requirements of dissolution testing: European Pharmacopoeia, Japanese Pharmacopoeia, United States Pharmacopeia / William E. Brown --
4. The role of dissolution testing in the regulation of pharmaceuticals: the FDA perspective / Vinod P. Shah --
5. Gastrointestinal transit and drug absorption / Clive G. Wilson and Kilian Kelly --
6. Physiological parameters relevant to dissolution testing: hydrodynamic considerations / Steffen M. Diebold --
7. Development of dissolution tests on the basis of gastrointestinal physiology / Sandra Klein, Erika Stippler, Martin Wunderlich and Jennifer Dressman --
8. Orally administered drug products: dissolution data analysis with a view to in vitro --
in vivo correlation / Maria Vertzoni, Eleftheria Nicolaides, Mira Symillides, Christos Reppas and Athanassios Iliadis. 9. Interpretation of in vitro --
in vivo time profiles in terms of textent, rate and shape / Frieder Langenbucher --
10. Study design considerations for IVIVC studies / Theresa Shepard, Colm Farrell and Myriam Rochdi --
11. Dissolution method development with a view to quality control / Johannes Krämer, Ralf Steinmetz and Erika Stippler --
12. Dissolution method development: an industry perspective / Cynthia K. Brown --
13. Design and qualification of automated dissolution systems / Dale VonBehren and Stephen Dobro --
14. Bioavailability of ingredients in dietary supplements: a practical approach to the in vitro demonstration of the availability of ingredients in dietary supplements / V. Srini Srinivasan.
Responsibility: edited by Jennifer Dressman, Johannes Krämer.
More information:

Abstract:

"A 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."--BOOK JACKET.

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