Exec Director Gilead Sciences, Inc. Foster City, California, United States
Impurities and degradation products (discussed herein as impurities) are part of the normal process of pharmaceutical drug substance (DS) and drug product (DP) development. For impurities above the qualification threshold, biological safety data is needed to show that the impurity is safe at the levels administered to patients. This session will give an introduction of impurity qualification, and how to calculate qualified limits. While current existing guidelines provide the framework for impurity qualification, this introduction will discuss in-practice strategies oftentimes used by pharmaceutical sponsors.
