posted on 2023-03-14, 17:05authored byBrandon G Santiago, Stephen H Eisennagel, Gregory E Peckham, Amanda M Liebhardt, Chad L Alburn, Theresa J Roethke, Michael A Reilly, Jens R Sydor, Molly Z Karlinsey
<p>As the desire for a shortened design/make/test/learn cycle increases in early drug discovery, the</p>
<p>pressure to rapidly deliver drug metabolism pharmacokinetic data continues to rise. From a bioanalytical</p>
<p>standpoint, in vitro assays are challenging because they are amenable to automation and thus capable</p>
<p>of generating a high number of samples for analysis. To keep up with analysis demands, automated</p>
<p>method development workflows, rapid sample analysis approaches and efficient data analysis software</p>
<p>must be utilized. This work provides an outline of how we implemented those three aspects to provide</p>
<p>bioanalytical support for in vitro drug metabolism pharmacokinetic assays, which include developing</p>
<p>hundreds of mass spectrometry methods and analyzing thousands of samples per week, while delivering</p>
<p>a median bioanalytical turnaround time of 1–2 business days.</p>