Ensuring biological sample integrity from collection to analysis for LC–MS workflows: case studies illustrating challenges in clinical trials

Abstract

In quantitative bioanalysis, ensuring sample integrity through the life cycle of a sample is crucial for providing reliable data. Sponsors must develop proper collection procedures to ensure high sample quality. Collection procedures should mitigate sample variability and stability concerns. Sample stability concerns can be managed with appropriate stabilization approaches like the addition of preservative, environmental exposure (temperature, humidity, light controls) and timely analysis with more frequent shipping. It is important that the bioanalytical scientist communicates specific needs to internal operations groups, the central laboratory and clinical sites. In large global trials, this is logistically challenging given the large number of sites and the potential language barriers. Several case studies presented below will illustrate logistical challenges with unstable compounds and unique matrices for LC–MS/MS workflows.