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).

摘要: The 2018 12th Workshop on Recent Issues in Bioanalysis took place Philadelphia, PA, USA April 9-13, with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - full immersion week bioanalysis, biomarkers immunogenicity. As usual, it specifically designed to facilitate sharing, reviewing, discussing agreeing approaches address the most current issues interest including both small- large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS LBA/cell-based assays approaches. This White Paper encompasses recommendations emerging extensive discussions held during workshop is aimed provide bioanalytical community key information practical solutions topics addressed, effort enable advances scientific excellence, improved quality better compliance. Due its length, edition this comprehensive has been divided into three parts for editorial reasons. publication (Part 2) covers PK, PD ADA by agencies' input. Part 1 (LCMS small molecules, peptides, oligonucleotides molecule biomarkers) 3 (LBA/cell-based assays: immunogenicity, PK assays) are published volume 10 Bioanalysis, 22 24 (2018), respectively.