Discussion on the Technical Requirements and Methods for In-use (CHINA)

Abstract: This article introduces the concept, significance, and applicability of in-use stability testing for drug products. The article references relevant domestic and foreign guidelines for drug stability studies and discusses methods for evaluating the in-use stability of drug products based on the kinetic model of drug degradation.

Best Practices • Best Practices • Determination • Extrapolation • Guidances • Life Cycle • Parameters • Regulations • Regulatory • Sample Control • Shelf-Life • Study Design • Study Types