Abstract
Forced degradation studies (stress testing) are very important tool in pharmaceutical research and development to predict long-term stability. Stress studies should be performed in method development to understand drug behavior but also can be performed with method validation for regulatory filling predict stability and measure impurities. For stable formulation development, understanding of chemical behavior, degradation pathways and degradation products of drug substance and drug product is very important. There is not much regulatory guidance available, which can provide step-by-step details on stress testing. Therefore, in present review paper we described the extensive overview of forced degradation studies (stress studies) by specifying strategy to perform stress studies and development of stability indicating method.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: Journal of Chromatography & Separation Techniques
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
