Stability assessment in ligand-binding assays: a critical parameter for data integrity

“...a great deal of confusion remains on how to assess and demonstrate stability in scientifically meaningful ways.” In the last 2 years at the Workshops on Recent Issues in Bioanalysis and the Crystal City V meetings, many questions regarding stability assessment of analytes have been raised. The questions varied from how the assessments are performed to specific stability related issues. Although the concepts on stability are discussed by regulatory agencies and in industry White papers [1–3], a great deal of confusion remains on how to assess and demonstrate stability in scientifically meaningful ways. While certain specific issues may be difficult...