title: 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.
abstract: 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.
authors: Merck Research Laboratories, WP 75B-300, West Point, Pennsylvania, 19486, USA, woolf@merck.com.
authors: Eric J
authors: EJ
authors: Woolf
authors: Stuart
authors: S
authors: McDougall
authors: Douglas M
authors: DM
authors: Fast
authors: Maristela
authors: M
authors: Andraus
authors: Matthew
authors: M
authors: Barfield
authors: Michael
authors: M
authors: Blackburn
authors: Ben
authors: B
authors: Gordon
authors: David
authors: D
authors: Hoffman
authors: Noriko
authors: N
authors: Inoue
authors: Gabriel
authors: G
authors: Marcelin-Jimenez
authors: Amy
authors: A
authors: Flynn
authors: Richard
authors: R
authors: LeLacheur
authors: Scott
authors: S
authors: Reuschel
authors: Ravisankar
authors: R
authors: Santhanam
authors: Patrick
authors: P
authors: Bennett
authors: Barbara
authors: B
authors: Duncan
authors: Roger
authors: R
authors: Hayes
authors: Berthold
authors: B
authors: Lausecker
authors: Abhishek
authors: A
authors: Sharma
authors: Kazutaka
authors: K
authors: Togashi
authors: Ravi Kumar
authors: RK
authors: Trivedi
authors: Miguel
authors: M
authors: Vago
authors: Stephen
authors: S
authors: White
authors: Hollie
authors: H
authors: Barton
authors: John A
authors: JA
authors: Dunn
authors: Raymond H
authors: RH
authors: Farmen
authors: Katja
authors: K
authors: Heinig
authors: Christopher
authors: C
authors: Holliman
authors: Junji
authors: J
authors: Komaba
authors: Maria Francesca
authors: MF
authors: Riccio
authors: Elizabeth
authors: E
authors: Thomas
mesh_terms: D019985:Benchmarking; D002138:Calibration; D002853:Chromatography, Liquid / Q000592:standards*; D032921:Consensus; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*