Regulatory Roundup: USP Hosts Symposium on Science and Standards

Sep 05, 2012
By PharmTech Editors

The US Pharmacopeia Convention (USP) held its first Science and Standards Symposium in Sao Paulo, Brazil, on August 23–24, 2012. The meeting focused on the importance of the Biopharmaceutics Classification System. Almost 300 regulators, academics, pharmaceutical manufacturers, and quality control experts from Latin American countries and the US attended the Symposium, which was cosponsored by the University of Sao Paulo.

According to a press release, Roger Williams, MD, chief executive officer of USP, closed the meeting by asking the attendees to think about a “global system of interchangeable products.” Williams stated, “If you have a highly soluble drug substance that is rapidly dissolving, it should be optimally bioavailable. Then, if you have two different products with the same active ingredients that are both optimally bioavailable, they should be bioequivalent.” According to release, “drug product monographs in the new USP Medicines Compendium, coupled with labeling, might advance the general approach for the classification and regulation of biopharmaceuticals.”