2
  • Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff

    Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff

    下载
  • 2019 White Paper on Recent Issues in Bioanalysis

    2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

    下载