2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

作者：Brian Booth, Lauren Stevenson, Renuka Pillutla, Michael H. Buonarati, Chris Beaver, Daniela Fraier, Fabio Garofolo, Sam Haidar, Rafiq Islam, Christopher James, John Kadavil, Olga Kavetska, Fumin Li, Christina Satterwhite, Natasha Savoie, Sriram Subramaniam, Nilufer Tampal, Theingi M. Thway, Eric Woolf, Olivier Le Blaye, Matthew Andisik, Chad Briscoe, Stephanie Cape, Arindam Das-Gupta, Sally Fischer, Sam Haidar, Roger Hayes, John Kamerud, Gustavo Mendes Lima Santos, Corey Nehls, Catherine Soo, Stephen Vinter, Emma Whale, Keyang Xu, Seongeun Cho, Anna Edmison, Sean Kassim, Thais Correa Rocha, Jan Welink, Shashi Amur, Abbas Bandukwala, Elana Cherry, Shirley Hopper, Akiko Ishii‐Watabe, Susan Kirshner, Kevin Maher, João Pedras-Vasconcelos, Yoshiro Saito, Therese Solstad Saunders, Venke Skibeli, Daniela Verthelyi, Yow‐Ming Wang, Haoheng Yan · 发表于：Bioanalysis · 年份：2019 · DOI：10.4155/bio-2019-0270 · 被引用次数：32 · 研究领域：Biosimilars and Bioanalytical Methods、Advanced Biosensing Techniques and Applications、Biosensors and Analytical Detection

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1–5 April 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. 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 bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 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 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on the 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy. Part 1 (Innovation in small molecules and oligonucleotides and mass spectrometry...