Application of Forced Degradation Testing in Drug Development

OBJECTIVE To expound the present situation of forced degradation, summarize the basic conditions of forced degradation testing, and provide guidance for drug research and development. METHODS The basic methods of drug forced degradation in actual work and literature were summarized, and the requirements of forced degradation at different phase of drug registration were analyzed. RESULTS At this stage, national regulatory agencies did not propose uniform conditions for forced degradation testing. The degradation conditions of the drug were related to the molecular structure and the formulation of the drug. CONCLUSION Forced degradation studies can help identify drug degradation pathways and analyze degradants, support drug safety and toxicology study, and support the development of stability indicator analytical methods, drug formulation, packaging and storage conditions. From the early to the late stage of drug development, forced degradation needs to be continuously improved.