%0 Journal Article
%T Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis | Bioanalysis
%A Allan Xu
%A Am
%A Anahita Keyhani
%A Andrew Dinan
%A Ardeshir Khadang
%A Arron Xu
%A Bruce Stouffer
%A Chad Briscoe
%A Chantal DiMarco
%A Chris Beaver
%A Christina Satterwhite
%A Clark Williard
%A Colin Barry
%A Corey Nehls
%A Curtis Sheldon
%A Dave Williams
%A Edward Tabler
%A Edward Wells
%A Eric Thomas
%A Franklin Spriggs
%A George Hristopoulos
%A Hanna Ritz¨Śn
%A Hao Feng
%A Hao Wang
%A Iohann Boulay
%A Ira DuBey
%A James Bourdage
%A Jenifer Vija
%A Jennifer Zimmer
%A Jenny Lin
%A Jessica St Charles
%A John Lindsay
%A John Stamatopoulos
%A Kathie Lindley
%A Kayode Awaiye
%A Lawrence Goodwin
%A Luigi DiMarco
%A Marc Moussallie
%A Maria Cruz Caturla
%A Mark Warren
%A Mathilde Yu
%A Michael Brown
%A Michele Malone
%A Mohammed Bouhajib
%A Nadia Kulagina
%A Natasha Savoie
%A Nicola Hughes
%A Patrick Bennett
%A Paul Rhyne
%A Philippe Couerbe
%A Rabab Tayyem
%A Rafiq Islam
%A Robert MacNeill
%A Roger Hayes
%A Shane Karnik
%A Sian Estdale
%A Simona Rizea Savu
%A Stephanie Cape
%A Sumit Kar
%A Vellalore Kakkanaiah
%A Wei Garofolo
%A Xinping Fang
%A Yi Qun Xiao
%A a Hays
%J Bioanalysis
%D 2019
%R https://doi.org/10.4155/bio-2019-0072
%X Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC membersĄŻ opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users
%U https://www.future-science.com/doi/10.4155/bio-2019-0072