The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.
By Bikash Chatterjee, chief operating and science officer, Pharmatech Associates
The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.