Stability Studies and Testing of Pharmaceuticals: An Overview
June 01, 2020
This instalment is the first in a series of three white papers on stability studies and testing of pharmaceuticals, as well as the development and validation of stability-indicating high performance liquid chromatography (HPLC) methods. The series is co-authored by Kim Huynh-Ba, a subject-matter expert on stability testing and regulatory compliance, and Michael Dong, the columnist on “Perspectives in Modern HPLC”. This first instalment provides a comprehensive and updated overview of stability studies and testing of small molecule drugs, current regulatory requirements, and industry practices for forced degradation, as well as possible approaches for reduced testing and data evaluation to expedite stability study timelines.