1999 Issues

Volume 6, Issue 1, February 1999

Developing Dissolution Tests for Modified Release Dosage Forms: General Considerations John R. Crison, PORT Systems, LLC, Ann Arbor, Michigan International Bioequivalence Meeting "Challenges in the Design and Evaluation of Bioequivalence" Enhanced Decision Making from Dissolution Automation Harnath Doddapaneni, John Jushchyshyn SmithKline Beecham Pharmaceuticals Research & Development Upper Merion, Pennsylvania Hollow ShaftTM Sampling Method in Dissolution Testing Richard Hengst, Rolf Rolli Sotax Corporation, Furlong Pennsylvania

May 1999, Volume 6, Issue 2

The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance A.S. Hussain, L.J. Lesko, K.Y. Lo, V.P. Shah, D. Volpe and R.L. Williams Office of Pharmaceutical Science, Center for Drug Evaluation and Research Food and Drug Administration, Rockville, MD Meeting Report: "Challenges in the Design and Evaluation of Bioequivalence" Co-sponsored by AAPS, AAPV, CRS, EUFEPS amd the FDA Frankfurt, Germany The Multicomponent Automated Dissolution System: An Alternative in the Development and Pharmaceutical Analysis of Generic PolyDrugs V. Fuerte (1) and M. Maldonado(2) (1)Centro de Investigacion y de Estudios Avanzados del IPN. Tepepan, Mexico (2)Department of Pharmacy, King's College London, Chelsea, UK Dissolution Testing of Nutritional Supplements C. Jean Taborsky1 and Royal Hanson2 (1) Scientific Regulatory Affairs Consultant, Columbia, MD (2) Hanson Research, Chatsworth, CA

Volume 6, Issue 3, August 1999

Fifth Anniversary Issue

Editor's letter Roles of Dissolution Testing: Regulatory, Industry and Academic Perspectives -Role of Dissolution Testing in Regulating Pharmaceuticals Vinod P. Shah and Roger L. Williams Office of Pharmaceutical Science,Center for Drug Evaluation and Research Food and Drug Administration, Rockville, MD -Role of Dissolution Testing in Pharmaceutical Industry Martin Siewert, Hoechst Marion Roussel, AG, Frankfurt, Germany -Future Directions for Academic Research in Dissolution Testing Jennifer B. Dressman Johann Wolfgang Goethe-University, Frankfurt/Main, Germany Recent Innovations in Dissolution Calibration Mary Oates, Warner-Lambert, Morris Plains, NJ Meeting Report:"AAPS Workshop on SUPACs: Where are We Going? Have We Reached the Limit? David C. Pang Director of Scientific Affairs, American Association of Pharmceutical Scientists Dissolution Profile Comparison Using Similarity Factor, f2 Vinod P. Shah, Yi Tsong, Pradeep Sathe and Roger L. Williams Office of Pharmaceutical Science, Center for Drug Evaluation and Research Food and Drug Administration, Rockville, MD

Volume 6, Issue 4, November 1999

Rethinking the Use of Water as a Dissolution Medium Carol Noory, Nhan Tran, Larry Ouderkirk, Sara Brown, Jesse Perry, José Lopez, Miquel Colon, Marisol Faberlle, Kermit Henry, Julie Rorberg, Syed Nasir Ali, and Vinod Shah Food and Drug Administration In Situ Dissolution Testing Using a Fiber Optic Probe Dissolution System Kevin C. Bynum, Erik Kraft, John Pocreva, Emil W. Ciurczak and Philip Palermo, Purdue Pharma, L.P.International R&D, Ardsley, NY New Feature: Question and Answer Section Meeting Report: FIP's Dissolution Expert Team Goes on the Road with Dissolution '99 Jennifer Dressman(1) and Johannes Kraemer(2) 1 University of Frankfurt, Germany 2 Laboratory and Quality Services, Eschborn, Germany Meeting Report: Dissolution Testing of Special Dosage Forms Worshop Helga Möller,(1) Vinod Shah,(2) and Cynthia Brown(3) 1 Zentrallaboratorium Deutscher Apotheker, Frankfurt Germany 2 Food and Drug Administration, Rockville, MD 3 Quintiles, Inc., Kansas City, MO