2002 Issues

Volume 9, Issue 1, February 2002

Dissolution/In Vitro Release Testing of Special Dosage Forms Vinod P. Shah, Food and Drug Administration, Rockville, MD Martin Siewert, Aventis Pharma, Frankfurt, Germany Jennifer Dressman, JW Goethe University, Frankfurt, Germany Helga Moeller, Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany Cynthia K. Brown, Quintiles, Inc., Kansas City, MO Update on Dissolution Testing-Recent Activities and Trends Vivian Gray, V. A. Gray Consulting, Inc., Hockessin, DE Refinement of Lower Acceptance Value of the Similarity Factor f2 in Comparison of Dissolution Profiles Mukesh C. Gohel and Maulik K. Panchal L.M. College of Pharmacy, Department of Pharmaceutics, Navrangpura, Ahmedabad, India

Volume 9, Issue 2, May 2002

An Industrial Implementation of the Biopharmaceutics Classification System Jack A. Cook, Ph.D. and Howard N. Bockbrader, Ph.D. Clinical Pharmacokinetics and Pharmacodynamics Department, Pfizer Global Research and Development, Ann Arbor, MI United States Pharmacopeia Establishes Project Team on Dissolution Calibration William Brown United States Pharmacopeia, Rockville, MD Meeting Report: AAPS/FDA Workshop on Drug Product and Drug Substance Specifications - Dissolution Summary Vivian A. Gray V. A. Gray Consulting, Inc., Hockessin, DE Questions and Answers

Volume 9, Issue 3, August 2002

Process Analytical Technology: Applications to the Pharmaceutical Industry Peter Scott Quality Assurance Analytical Services , Method Services AstraZeneca, Westborough, MA United States Pharmacopeia News -USP Forms Working Group on HPLC Column -USP Seeks Public Comment for Sixteen Proposed Dietary Supplement Monographs Automation of Dissolution Tests for Biowaiver Studies Rolf Rolli SOTAX Group, Allschwil, Switzerland Questions and Answers William Brown and Margareth Marques United States Pharmacopeia, Rockville, MD

Volume 9, Issue 4, November 2002

Drug Release Characteristics of Different Mesalazine Products Using USP Apparatus 3 to Simulate Passage Through the GI Tract Sandra Klein, Markus W. Rudolph, Jennifer B. Dressman Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany SIG-BA/BE: Its Structure, Functions and Activities Vinod P. Shah, Martin Siewert, and Hans Junginger Federation Internationale Pharmaceutique, Board of Pharmaceutical Sciences, Special Interest Group on Bioavailability / Bioequivalence (FIP-BPS-SIG BA/BE) Co-chairs Meeting Report: AAPS/FDA Workshop on Dissolution/In Vitro Release Testing and Specifications for Special Dosage Forms Vivian A. Gray, V. A. Gray Consulting, Hockessin, DE Meeting Report: AAPS/FDA Workshop on Biopharmaceutics Classification System Vivian A. Gray V. A. Gray Consulting, Hockessin, DE