Inventaire - your friends and communities are your best library - Inventaire

Building a roadmap to biomarker qualification: challenges and opportunities

published in: Biomarkers in Medicine

date of publication: 2015-11-03

language: English

main subject: biomarker

Cites articles 12

Date

Title

Authors

2015-01-28

Catalyzing the Critical Path Initiative: FDA's progress in drug development activities
2015-06-06

Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization
2014-10-13

Multiplicity and replicability: two sides of the same coin

Frank Bretz
2013-07-20

Qualification of cardiac troponins for nonclinical use: a regulatory perspective
2011-09-01

Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview.

Janet Woodcock
2011-05-18

Biological qualification of biomarkers of chemical-induced renal toxicity in two strains of male rat.
2010-05-01

Urinary clusterin, cystatin C, beta2-microglobulin and total protein as markers to detect drug-induced kidney injury

Elias Perentes, Daniel Robert Roth
2010-05-10

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

David Gerhold, Jonathan A Phillips, Gerald Maurer, Sean P Troth
2007-03-23

Biomarker qualification pilot process at the US Food and Drug Administration
2006-02-01

Diagnosis using predictive probabilities without cut-offs.
2006-03-01

Retrospective validation of genomic biomarkers-- what are the questions, challenges and strategies for developing useful relationships to clinical outcomes-- workshop summary
2001-03

Biomarkers and surrogate endpoints: preferred definitions and conceptual framework

Article - wd:Q38622968

Welcome to Inventaire

the library of your friends and communities

you are offline