2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity). Hendrik Neubert , Timothy Olah , Anita Lee , Stephanie Fraser , Robert Dodge , Omar Laterza , Matthew Szapacs , Stephen C Alley , Ola M Saad , Shashi Amur , Linzhi Chen , Elana Cherry , Seongeun Julia Cho , Isabelle Cludts , Lorella Di Donato , Anna Edmison , Luca Ferrari , Fabio Garofolo , Sam Haidar , Shirley Hopper , Scott Hottenstein , Akiko Ishii-Watabe , Sean Kassim , Pekka Kurki , Gustavo Mendes Lima Santos , Gilles Miscoria , Joe Palandra , João Pedras-Vasconcelos , Steven Piccoli , Sarah Rogstad , Yoshiro Saito , Natasha Savoie , Timothy Sikorski , Susan Spitz , Ludovicus Staelens , Daniela Verthelyi , Stephen Vinter , Meenu Wadhwa , Yow-Ming Wang , Jan Welink , Naidong Weng , Emma Whale , Eric Woolf , Jiang Wu , Haoheng Yan , Hongbin Yu , Shaolian Zhou BIOANALYSIS（2018）
Key words
immunogenicity assays, bioanalysis, biomarkers, regulatory feedback
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