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White Paper

2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV) (Part 1 – Small Molecules, Peptides and Small Molecule Biomarkers by LCMS)

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Pages 2363-2378 | Received 30 Sep 2016, Accepted 30 Sep 2016, Published online: 07 Oct 2016

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Hendrik Neubert, An Song, Anita Lee, Cong Wei, Jeff Duggan, Keyang Xu, Eric Woolf, Chris Evans, Joe Palandra, Omar Laterza, Shashi Amur, Isabella Berger, Mark Bustard, Mark Cancilla, Shang-Chiung Chen, Seongeun (Julia) Cho, Eugene Ciccimaro, Isabelle Cludts, Laurent Cocea, Celia D’Arienzo, Lieza Danan-Leon, Lorella Di Donato, Fabio Garofolo, Sam Haidar, Akiko Ishii-Watabe, Hao Jiang, John Kadavil, Sean Kassim, Pekka Kurki, Olivier Le Blaye, Kai Liu, Rod Mathews, Gustavo Mendes Lima Santos, Makoto Niwa, João Pedras-Vasconcelos, Mark Qian, Brian Rago, Ola Saad, Yoshiro Saito, Natasha Savoie, Dian Su, Matthew Szapacs, Nilufer Tampal, Stephen Vinter, Jian Wang, Jan Welink, Emma Whale, Amanda Wilson & Y-J Xue. (2017) 2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs). Bioanalysis 9:23, pages 1895-1912.
Read now
Jan Welink, Eric Yang, Nicola Hughes, Brian Rago, Eric Woolf, Jens Sydor, Laura Coppola, Brad Ackermann, Wenkui Li, Stephen C Alley, Mark Arnold, Isabella Berger, Chad Briscoe, Michael Buonarati, Mark Bustard, Mark Cancilla, Seongeun (Julia) Cho, Jeff Duggan, Daniela Fraier, Fabio Garofolo, Rachel Green, Sam Haidar, Lucinda Hittle, Akiko Ishii-Watabe, Rafiq Islam, Rand Jenkins, Barry Jones, John Kadavil, Sean Kassim, Olga Kavetska, Olivier Le Blaye, Anita Lee, Hanlan Liu, John Mehl, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Sekhar Surapaneni, Matthew Szapacs, Nilufer Tampal, Tom Verhaeghe, Stephen Vinter & Emma Whale. (2017) 2017 White Paper on Recent Issues in Bioanalysis: Aren’t Bmv Guidance/Guidelines ‘Scientific’? (Part 1 – LCMS: Small Molecules, Peptides and Small Molecule Biomarkers). Bioanalysis 9:22, pages 1807-1825.
Read now
Sankeetha Nadarajah. (2017) Welcome to Volume 9 of Bioanalysis. Bioanalysis 9:2, pages 151-154.
Read now
Mark E Arnold, Hendrik Neubert, Lauren F Stevenson & Fabio Garofolo. (2016) The Breadth of Biomarkers and Their Assays. Bioanalysis 8:22, pages 2283-2285.
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