The FDA/critical path initiative/Duke-Margolis center for health policy public workshop on analytical validation of assays for biomarker qualification: an update on the White Paper

Steven P Piccoli

doi:10.4155/bio-2018-0125

The FDA/critical path initiative/Duke-Margolis center for health policy public workshop on analytical validation of assays for biomarker qualification: an update on the White Paper

Bioanalysis. 2018 Jun 1;10(12):893-896. doi: 10.4155/bio-2018-0125. Epub 2018 Jun 20.

Author

Steven P Piccoli¹

Affiliation

¹ Neoteric Consulting, Princeton, NJ 08540, USA.

PMID: 29924636
DOI: 10.4155/bio-2018-0125

No abstract available

Keywords: biomarker assay validation; biomarker qualification; consensus scientific framework; drug development tools; evidentiary criteria; safety biomarkers.

Publication types

Editorial

MeSH terms

Biomarkers / analysis*
Chemistry Techniques, Analytical / standards*
Congresses as Topic
Education*
Health Policy*
Reproducibility of Results
United States
United States Food and Drug Administration

Substances

Biomarkers