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2017 White Paper on recent issues in bioanalysis: Aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: Small molecules, peptides and small molecule biomarkers)

Welink, Jan and Yang, Eric and Hughes, Nicola and Rago, Brian and Woolf, Eric and sydor, jens and coppola, laura and ackermann, brad and Li, Wenkui and alley, stephen and arnold, mark and berger, isabella and briscoe, chad and buonarati, michael and bustard, mark and cancilla, mark and cho, seongeun and duggan, jeff and fraier, daniela and garofolo, fabio and green, rachel and haidar, sam and hittle, lucinda and ishiiwatabe, akiko and islam, rafig and jenkins, rand and jones, barry and kadavil, john and kassim, sean and kavetska, olga and le blaye, olivier and lee, anita and liu, hanlan and mehl, john and mendes, gustavo and santos, lima and musuku, adien and ramanathan, ragu and saito, yoshiro and savoie, natasha and summerfield, scott and surapaneni, sekhaer and szapacs, matthew and tampal, nilufer and verhaegher, tom and vinter, stephen and whale, emma (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). pp. 1807-1825. ISSN 17576199

Abstract

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 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, 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 ligand-binding assay (LBA) approaches. This 2017 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. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for Small Molecules, Peptides and Small Molecule Biomarkers using LCMS. Part 2 (Biotherapeutics, Biomarkers and Immunogenicity Assays using Hybrid LBA/LCMS and Regulatory Agencies' Inputs) and Part 3 (LBA: Immunogenicity, Biomarkers and PK Assays) are published in volume 9 of Bioanalysis, issues 23 and 24 (2017), respectively.

Item Type: Article
Date Deposited: 28 Jul 2018 00:45
Last Modified: 28 Jul 2018 00:45
URI: https://oak.novartis.com/id/eprint/34145

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