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 Buonarati , Chris Beaver
关键词:
摘要: The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place New Orleans, LA 1-5 April with an attendance of over 1000 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 gene therapy. 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/flow cytometry assays qPCR 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 2018 FDA BMV guidance, ICH M10 draft guideline agencies' input Part 1 (Innovation small molecules oligonucleotides mass spectrometry method development strategies large bioanalysis) 3 (New insights biomarker assay validation, effective critical reagent management, flow validation drug discovery CLSI H62, interpretation guidance therapy challenges) are published volume 10 Bioanalysis, 22 24 (2019), respectively.
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