2003 Issues

Volume 10, Issue 1, February 2003

FIP/AAPS Guidelines for Dissolution/ In Vitro Release Testing of Novel/Special Dosage Forms Martin Siewert,1 Jennifer Dressman,2 Cynthia Brown,3 Vinod Shah 4 Aventis, Frankfurt, Germany 2 JW Goethe University, Frankfurt, Germany 3 Eli Lilly and Company, Indianapolis, IN 4 Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD Examination of Selection of Immediate Release Dissolution Acceptance Criteria Jeffrey D. Hofer1 and Vivian A. Gray2 1 Eli Lilly and Company, Indianapolis, IN 2 V. A. Gray Consulting, Inc., Hockessin, DE Question & Answer Section Margareth Marques, Ph.D. and Will Brown United States Phamacopeia, Rockville, MD Non-destructive Dissolution Testing Correlation Kuny T.,2 Schatz C.,1 Ulmschneider M.,1 Marrer S.,1, 2 Leuenberger H.2 1 Pharmaceutical Quality Assurance and Quality Control, F. Hoffmann-La Roche, Ltd, Basel, Switzerland 2 Institute of Pharmaceutical Technology, University of Basel, Switzerland

Volume 10, Issue 2, May 2003

Dissolution Testing of Orally Disintegrating Tablets James Klancke Sr. Director, Analytical Development CIMA LABS INC., Brooklyn Park, MN Development and Validation of In Vitro Release Tests for Semisolid Dosage Forms­Case Study Kailas D. Thakker, Ph.D.,1 and Wendy H. Chern, Ph.D.,2 1 President, Analytical Solutions, Raleigh, NC 2 Director, Product Development, Dermik Laboratories, Berwyn, PA Meeting Report: Workshop on "Hands On Dissolution and Bioequivalence" Professor Hans E. Junginger Scientific Secretary of Federation Internationale Pharmaceutique (FIP, International Pharmaceutical Federation) Question & Answer Section Margareth Marques, Ph.D. and Will Brown United States Phamacopeia, Rockville, MD

Volume 10, Issue 3, August 2003

Intrinsic Dissolution Performance Testing of the USP Dissolution Apparatus 2 (Rotating Paddle) Using Modified Salicylic Acid Calibrator Tablets: Proof of Principle John Mauger, 1, John Ballard, 2, Robert Brockson, 2, Sinjan De, 3, Vivian Gray, 4, and Dennis Robinson, 3 1 Professor, Pharmaceutics and Dean, University of Utah, Salt Lake City,Utah 2 DuPont Pharmaceuticals,Greenville,DE 3 Nebraska Medical Center,Omaha,NE 4 V. A. Gray Consulting, Inc,Hockessin, DE Overview on Chirality and Applications of Stereoselective Dissolution Testing in Formulation and Development Work Mukesh C.Gohel Professor and Principal L. M.College of Pharmacy, Ahmedabad, India Question and Answer Section Margareth Marques and Will Brown United States Pharmacopeia, Rockville,MD Meeting Report:Workshop on "Dissolution Technology and Bioequivalence" Professor Hans E. Junginger Scientific Secretary of Federation Internationale Pharmaceutique (FIP, International Federation)

November 2003 Volume 10 Issue 4

In Situ Dissolution Testing using Different UV Fiber Optic Probes and Instruments Xujin Lu, Ruben Lozano, Pankaj Shah Pharmaceutical Research Institute, Bristol-Myers Squibb, Analytical R and D, New Brunswick, NJ Practical Considerations When Using Fiber Optics for Dissolution Testing Martin Wunderlich, 1 Terry Way, 2 Jennifer Dressman, 1 1. Department of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main,Germany 2 Varian LTD,Walton-on-Thames, Surrey KT 12 2 QF England In Situ Fiber Optic Dissolution Monitoring of a Vitamin B12 Solid Dosage Formulation Christopher Toher, Per Nielsen, Alexis Foreman, Alex Avdeef Delphian Technology, Inc.,Woburn, MA Quantitative Assessment of Probe and Spectrometer Performance for a Multi-Channel CCD-based Fiber Optic Testing System Guy Inman Automation Resources, Hillsborough,NC Dissolution Testing Using Fiber OpticsóA Regulatory Perspective Vivian A. Gray V. A. Gray Consulting, Inc., Hockessin, DE Evaluating the Utility of Fiber Optic Analysis for Dissolution Testing of Drug Products Christopher Martin Varian, Inc., Dissolution Systems, Cary,NC Question & Answer Section Margareth Marques and William Brown United States Pharmacopeia, Rockville,MD