Research

Biomarker discovery
0 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)

Part two of the White Paper published in Bioanalysis from the 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) covers the FDA BMV guidance and the ICH M10 BMV Guideline and Regulatory inputs.

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