Bioanalysis Zone

Outsource-ability of high-resolution MS-based DMPK assays

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Bioanalytical assay support in the drug discovery environment has been an ever evolving field over the past few decades. Sample preparation, chromatography methods, ionization sources and mass analyzers continue to improve to meet the changing needs of industry. Such assay support is paramount in investigating early drug metabolism (DM) and PK studies that enable compound selection, dose predictions and allow progressing a candidate toward regulated, and eventually to, clinical studies. Project teams typically prefer consistency among bioanalytical approaches as compounds progress through various stage gates. However, as we enter into newer chemical space with an emphasis on complex modalities such as oligonucleotides, nanoparticles and antibody–drug conjugates (ADCs), the bioanalytical scientist is forced to look toward newer technology for advantages in selectivity, sensitivity and robustness of operation.

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