Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?
AAPS J
.
2022 May 5;24(3):65.
doi: 10.1208/s12248-022-00708-y.
Authors
Amanda Hays
1
,
Lakshmi Amaravadi
2
,
Carmen Fernandez-Metzler
3
,
Lindsay King
4
,
Joel Mathews
5
,
Yan Ni
6
,
Karen Quadrini
6
,
Chunyan Tinder
7
,
Faye Vazvaei
8
,
Jianing Zeng
7
Affiliations
1
BioAgilytix Labs, 2300 Englert Drive, Durham, NC, 27713, USA. Amanda.hays@bioagilytix.com.
2
Boston Pharmaceuticals, Cambridge, MA, USA.
3
Pharmacadence Analytical Services, Hatfield, PA, USA.
4
Pfizer Inc., Cambridge, MA, USA.
5
Ionis Pharmaceuticals, Carlsbad, CA, USA.
6
Passage Bio, Inc., Philadelphia, PA, USA.
7
Bristol Myers Squibb, Princeton, NJ, USA.
8
Merck & Co. Inc., Rahway, NJ, USA.
PMID:
35511303
DOI:
10.1208/s12248-022-00708-y
No abstract available
Keywords:
ISR; biomarker stability; biomarkers; eQC; parallelism.
MeSH terms
Biological Assay*
Biomarkers
Reproducibility of Results
Substances
Biomarkers