Stability Testing and Forced Degradation Studies in Drug Development: Principles and Practices

Abstract

Stability testing and forced degradation studies play a critical role in pharmaceutical drug development, ensuring the quality, safety, and efficacy of drug substances and products throughout their shelf life. These studies form the backbone of regulatory submissions and quality assurance, addressing potential degradation pathways and identifying intrinsic stability characteristics. This paper provides a comprehensive analysis of the principles, methodologies, challenges, and regulatory landscape associated with stability and degradation studies in modern drug development.

Keywords: Stability testing, Forced degradation, Drug development, ICH guidelines, Pharmaceutical quality