Publications by authors named "Daniel E Mulvana"
Article Synopsis
- High-resolution mass spectrometry (HRMS) is increasingly used in discovery workflows, but its adoption in late-stage drug development has been slow.
- Recent reports suggest that while HRMS can produce data suitable for regulated bioanalysis, it previously lacked the sensitivity needed for very low concentration assays (sub ng/ml).
- Advances in HRMS technology, particularly the Q-Exactive series, have improved sensitivity and selectivity, making it a viable option for regulated quantitative bioanalysis.
The use of LC-MS for bioanalysis of pharmaceuticals is entering its third decade and may be considered to be a mature technology. In many respects this is true, considering the advances made in such areas as instrument performance, electronics, software and automation of use. However, there remain instrumental and noninstrumental areas that require significant attention to ensure data quality.
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