1997 Issues

Volume 4, Issue 1, February 1997

ANDA Dissolution Method Development and Validation

Lewis J. Leeson, Ph.D., LJL Associates, Inc., Montville, NJ

AAPS/CRS/FDS Workshop in Scientific Foundation and Applications for the BCS and In Vitro-In Vivo Correlations

New and Extended Applications for USP Drug Release Apparatus 3

Ian Borst (1), Sydney Ugwu (2), and A. H. Beckett (3)
(1) Drug Testing Laboratory, laboratory Service Branck, Ministry of Health, Ontario, Canada;
(2) VanKel Industries, Inc. R&D Laboratory, Edison, NJ
(3) Professor Emeritus, University of London, U.K.

Considerations for Choosing a Dearation Technique for Dissolution Media

M.F. Griffin, T.E. Curley, and G.P. Martin
Merck & Co. West Point, PA

Volume 4, Issue 2, May 1997

A Recommendation for Reduced Dissolution Calibration Testing

PhRMA Dissolution Test Working Group;
PhRMA Subcommittee on Dissolution Calibration

Calibration of the USP 3 (Reciprocating Cylinder) Dissolution Apparatus

Brian R. Rohrs, Ph.D.
Pharmaceutical Development, Pharmacia & Upjohn

USP Apparatus 4 - Applying the Technology

Terry J. Looney, SOTAX Corporation

Volume 4, Issue 3, August 1997

In Vitro Evaluation of Drug Release from Modified Release Delivery Systems: Initial Experiences with Calibrators for USP Dissolution Apparatus 3

N.B. Takiar & R..G. Hollenbeck
Baltimore District FDA & MAB, School of Pharmacy

Setting Dissolution Specifications

Robert C. Wojcik, Ph.D.
Wyeth-Ayerst/Lederle Laboratories

Scientific Issues with a Business Impact: In Vitro-In Vitro Workshop

Volume 4, Issue 4, November 1997

FIP Guidelines for Dissolution Testing of Solid Oral Products

FDA Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms

FDA Guidance for Industry Extended Release Solid Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlations