1. 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)
- Author
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Ragu Ramanathan, Christopher P. Evans, Rachel Sun, Eugene Ciccimaro, Corey Nehls, Ronald Bauer, Eric Yang, Adrien Musuku, Rand Jenkins, Lloyd King, Daniela Fraier, Jason Wakelin-Smith, Chad Briscoe, Dieter M. Drexler, Christopher A. James, Michael H. Buonarati, Wenkui Li, Jan Welink, Laura Coppola, Gustavo Mendes Lima Santos, Stephanie Cape, Dina Goykhman, Rafiq Islam, Yoshiro Saito, Scott G. Summerfield, Raj Dodda, Steve Vinter, Amanda Wilson, Nicola Hughes, Nilufer Tampal, Stephanie Croft, Neil Addock, Qin Yue, Natasha Savoie, Mark Bustard, Fabio Garofolo, Eric Woolf, Mark E. Arnold, John Kadavil, Jens Sydor, and Luca Ferrari
- Subjects
Engineering ,Bioanalysis ,business.industry ,010401 analytical chemistry ,Clinical Biochemistry ,General Medicine ,030226 pharmacology & pharmacy ,01 natural sciences ,Data science ,0104 chemical sciences ,Analytical Chemistry ,Biotechnology ,03 medical and health sciences ,Medical Laboratory Technology ,0302 clinical medicine ,Biopharmaceutical ,White paper ,General Pharmacology, Toxicology and Pharmaceutics ,business - Abstract
The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event – A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This white paper is published in 3 parts due to length. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LCMS. Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in the Bioanalysis journal, issue 23.
- Published
- 2016