Small molecule specific run acceptance, specific assay operation, and chromatographic run quality assessment: Recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Teams
Woolf E.J.,Merck And Co. |
McDougall S.,Covance |
Fast D.M.,Covance Laboratories Inc. |
Andraus M.,ChromAnalysis |
And 27 more authors.
AAPS Journal | Year: 2014
Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance. © 2014 American Association of Pharmaceutical Scientists.