Fit-for-purpose biomarker immunoassay qualification and validation: three case studies.
Bioanalysis
; 8(22): 2329-2340, 2016 Nov.
Article
in En
| MEDLINE
| ID: mdl-27712082
ABSTRACT
AIM:
To improve on the efficiency of biomarker assay readiness, and for reliable biomarker data to support three drug programs, we implemented a fit-for-purpose approach, qualifying two biomarker assays and validating a third. Results/methodology:
The qualification strategy and selection of experiments for two exploratory biomarkers (CXCL1, CCL19) was determined by the intended use of the biomarker data. The third biomarker, IL-6, was validated as the data would be used in monitoring patient safety during dose-escalation studies in a Phase I trial. All three assays passed a priori acceptance criteria.CONCLUSION:
These assays highlight strategies and methodologies for a fit-for-purpose approach. Minimum qualification, full qualification and validation were chosen and supported programs at different stages of drug development.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Language:
En
Journal:
Bioanalysis
Year:
2016
Document type:
Article
Affiliation country:
Estados Unidos