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

Overview

Journal AAPS J

Specialty Pharmacology

Date 2014 Jun 26

PMID 24961918

Citations 6

Authors

Eric J Woolf

Stuart McDougall

Douglas M Fast

Maristela Andraus

Matthew Barfield

Michael Blackburn

Ben Gordon

David Hoffman

Noriko Inoue

Gabriel Marcelin-Jimenez

Amy Flynn

Richard LeLacheur

Scott Reuschel

Ravisankar Santhanam

Patrick Bennett

Barbara Duncan

Roger Hayes

Berthold Lausecker

Abhishek Sharma

Kazutaka Togashi

Ravi Kumar Trivedi

Miguel Vago

Stephen White

Hollie Barton

John A Dunn

Raymond H Farmen

Katja Heinig

Christopher Holliman

Junji Komaba

Maria Francesca Riccio

Elizabeth Thomas

Affiliations

Soon will be listed here.

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.

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