Biomarker assays: is it time for a standalone regulatory guidance?

Bioanalysis. 2018 Dec;10(23):1893-1895. doi: 10.4155/bio-2018-0279. Epub 2018 Nov 16.

Authors

Steve Keller¹, Shobha Purushothama²

Affiliations

¹ AbbVie Biotherapeutics 1500 Seaport Blvd Redwood City, CA 94063, USA.
² Biogen, 225 Binney Street, Cambridge, MA 02142, USA.

PMID: 30442025
DOI: 10.4155/bio-2018-0279

No abstract available

Keywords: biomarker assay; context of use; fit for purpose; parallelism; relative accuracy; surrogate matrix.

Publication types

Editorial

MeSH terms

Biological Assay*
Biomarkers / analysis
Humans
Pharmaceutical Preparations / analysis*

Substances

Biomarkers
Pharmaceutical Preparations