Workshop Report: Current Performance Testing for Pharmaceutical and TCM Dosage Forms

On October 23–24, 2008, the Shanghai University
of Traditional Chinese Medicine sponsored a
workshop on the pressing issue of performance
and quality benchmarks for conventional and traditional
medicines. Dr. Gordon Amidon from the College of
Pharmacy at the University of Michigan, who is the father
of the Biopharmaceutical Classification System (BCS), gave
a comprehensive overview of the current status and the
future implication of the BCS for the pharmaceutical
and traditional industry. The U.S. FDA uses the BCS for
regulatory decisions. One of the most important uses of
the BCS classification is to define which drug products
may qualify for Biowaivers in the pre- and post-approval
phases. The principles of the BCS can benefit traditional
drugs by classifying their components. This will help to set
meaningful quality control standards for botanical
remedies. Dr. Erika Stippler, director of dosage form
performance laboratory of the United States
Pharmacopeia, spoke about the importance of the new
USP performance verification test. She showed how the
physical calibration of a dissolution apparatus can impact
results. However, other factors like the laboratory
environment and the degassing technique, together with
the work style of analyst, might influence the results to an
even higher degree. Dr. Raimar Löbenberg, University
of Alberta, gave an overview of the current status of in
vitro–in vivo correlation and its implications for traditional
medicines.