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