Biomarker assay validation

Current situation on biomarker validation in Japan

(2018) Yoshiro Saito et al.   Bioanalysis

An industry perspective on the US FDA biomarker qualification effort

(2018) Mark E Arnold   Bioanalysis

Adaptation of commercial biomarker kits and proposal for ‘drug development kits’ to support bioanalysis: call for action

(2018) Rafiqul Islam et al.   Bioanalysis

Clinical biomarker validation

(2018) John L Allinson   Bioanalysis

Singlicate analysis: should this be the default for biomarker measurements using ligand-binding assays?

(2018) Zhuqiu Ye et al.   Bioanalysis

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

(2018) Steven P Piccoli   Bioanalysis

Parallelism: the foundation of biomarker assay development and validation

(2018) Devangi Mehta et al.   Bioanalysis

Evolution of fit-for-purpose biomarker validations: an LBA perspective

(2018) Robert J Neely   Bioanalysis

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays)

(2017) Shalini Gupta et al.   Bioanalysis

Workshop Report: Crystal City VI—Bioanalytical Method Validation for Biomarkers

(2016) Mark E. Arnold et al.   AAPS Journal

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)

(2016) Susan Richards et al.   Bioanalysis

Building a roadmap to biomarker qualification: challenges and opportunities

(2015) Shashi G Amur et al.   Biomarkers in Medicine

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)

(2015) Lakshmi Amaravadi et al.   Bioanalysis

Recommendations on biomarker bioanalytical method validation by GCC

(2012) Richard Hougton et al.   Bioanalysis

Method validation and application of protein biomarkers: basic similarities and differences from biotherapeutics

(2010) Jean W Lee   Bioanalysis

Method validation of protein biomarkers in support of drug development or clinical diagnosis/prognosis☆

(2008) Jean W. Lee et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES