Crucial importance of evaluating internal standards (IS) response and troubleshooting in effective LCMS method development, validation and sample analysis

To achieve this, a constant amount of IS is added to all samples - except for a double blank in a batch - including calibration standards (CALS), quality controls (QCs), and subject samples prior to the initiation of extraction procedures. [...]by design, the responses of IS from all samples in an a...

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Bibliographic Details
Published in:Bioanalysis 2019-09, Vol.11 (18), p.1645-1647
Main Authors: Cho, Seongeun Julia, Vinter, Stephen, Garofolo, Fabio
Format: Article
Language:English
Subjects:
Accuracy
Biomarkers
Case studies
Chromatography
R&D
Regulatory agencies
Research & development
Trends
Trouble shooting
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Summary:To achieve this, a constant amount of IS is added to all samples - except for a double blank in a batch - including calibration standards (CALS), quality controls (QCs), and subject samples prior to the initiation of extraction procedures. [...]by design, the responses of IS from all samples in an analytical run are anticipated to be similar to each other. Additional investigations and proper documentation may be warranted when unusual IS responses are observed” (6). [...]it was decided that more training was needed to harmonize industry practice and regulatory expectations. [...]a full day industry/regulators training session with numerous case studies and panel discussions were organized during the 12th WRIB (2018) in Philadelphia (7). [...]Le Blaye (French National Agency for Medicines and Health Products Safety [ANSM]; Saint-Denis, France) discusses how objective numerical criteria are useful for deciding to re-analyze individual samples, however, a visual inspection of plots of IS response could be better for monitoring trends or systematic differences (16).
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2019-0245