In this white paper, we show testing of two critical parameters for the method validation of Gyrolab: 1) carryover contamination and 2) after MRD (minimum required dilution) stability.

Assessing a compound’s stability is a complex and lengthy process with objectives varying by the development phase. A poorly designed stability study can cause delays that extend to years, create significant budget overruns, and even result in product failure. Thus, stability testing requires scientific expertise and very specialized experience to minimize development costs and avoid severe consequences. This webinar discusses the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.

In this study, we develop an LC-MS/MS assay for quantifying Azacitidine in Human Plasma and apply this method to support a phase ½ clinical study on the efficacy of Azacitidine in cancer subjects.