Abstract

Forced Degradation: Regulatory Perspectives, Benefits and Advancements

Saranjit Singh, Professor/Head, NIPER Mohali

Forced degradation is a term synonymous with many other phrases like stress testing, forced decomposition study, stress study, stress degradation study and stress decomposition study. The same was formalized under the heading ‘stress testing’ by ICH in its parent stability testing guideline Q1A in 1993. It has now been extended to generic drugs. The topic has attracted huge interest from regulatory agencies globally and also scientists working in industry as well as academia. The presentation will focus on regulatory perspectives and delve into topics like forced degradation timing, study protocols, etc. It will also enumerate multiple benefits of stress testing. The advancements in forced degradation area will also be discussed.