Bioanalysis Zone

A simple, effective approach for rapid development of high-throughput and reliable LC–MS/MS bioanalytical assays

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Quality and throughput are two primary goals for developing and optimizing LC–MS/MS bioanalytical methods. Various approaches and techniques have been evaluated and applied to LC–MS/MS bioanalysis to achieve these goals [1–11]. In addition to the throughput and quality of the bioanalytical assay itself, the speed of method development is also important. Depending on the stage of drug research and the scope of supported studies, the requirements (quality, throughput, sensitivity, etc.) of bioanalytical assays are quite different. Various method development strategies are needed to meet the requirements in different situations. In the discovery stage, bioanalysis is mostly used for exploratory purposes and focuses more on sample throughput. For example, to achieve higher speed in method development, Naidong et al. [9] used a ‘N in 1’ approach to develop LC–MS/MS methods for six different analytes simultaneously, which significantly improved the method development throughput. In the development stage, to support preclinical and clinical studies, a very sound and reliable bioanalytical method is needed. In regulated bioanalysis, the focus is more on quality and compliance with regulations. A more thorough method development and rigorous validation according to regulatory guidance [12,13] are required to minimize potential bioanalytical risks and ensure assay quality.

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