Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based bioanalysis

In this research article, the authors investigate the differences between two methods for matrix-based stability testing. This article is from the special focus issue published by Bioanalysis on Stability Issues in Bioanalysis.   Keywords: bioanalysis, method validation, regulatory, small molecule, stability Aim: Contract research organizations and pharmaceutical firms have performed stability testing using one of two methods: storing in the freezer a single tube of matrix for each quality control concentration (Method 1), followed by aliquoting and analysis; and storing three tubes for each quality control concentration, followed by analysis (Method 2). This research project was conducted to determine if there were detectable differences between Method 1...