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  Ligand Binding Assay Bioanalytical Focus Group Long Term Goals (5-Year Plan)

  • Develop strategic plan for LBABFG
  • Lead effort to address unresolved issues pertaining to the validation of quantitative LBAs
  • Achieve a pharmaceutical industry consensus for harmonizing of Pre-study & In-study validation of LBAs
  • Provide Education for LBAs
    • workshops and short courses
  • Lead effort to standardize validation of in vitro assays for:
    • biomarkers
    • host antibodies for immunogenicity assessments
    • PD antibody response of vaccines
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10/17/2008

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