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.

Autor: Woolf EJ; Merck Research Laboratories, WP 75B-300, West Point, Pennsylvania, 19486, USA, woolf@merck.com., McDougall S, Fast DM, Andraus M, Barfield M, Blackburn M, Gordon B, Hoffman D, Inoue N, Marcelin-Jimenez G, Flynn A, LeLacheur R, Reuschel S, Santhanam R, Bennett P, Duncan B, Hayes R, Lausecker B, Sharma A, Togashi K, Trivedi RK, Vago M, White S, Barton H, Dunn JA, Farmen RH, Heinig K, Holliman C, Komaba J, Riccio MF, Thomas E
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2014 Sep; Vol. 16 (5), pp. 885-93. Date of Electronic Publication: 2014 Jun 25.
DOI: 10.1208/s12248-014-9633-4
Abstrakt: 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.
Databáze: MEDLINE
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