Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons

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

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

Simple Plex™: A Novel Multi-Analyte, Automated Microfluidic Immunoassay Platform for the Detection of Human and Mouse Cytokines and Chemokines

(2016) Paulomi Aldo et al.   AMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY

Commercial biomarker assays: friend and foe

(2016) Saloumeh K Fischer et al.   Bioanalysis

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

AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers

(2016) Steve Lowes et al.   Bioanalysis

Implementing fit-for-purpose biomarker assay approaches: a bioanalytical perspective

(2016) Kyra J Cowan   Bioanalysis

Multicenter immunoassay validation of cerebrospinal fluid neurofilament light: a biomarker for neurodegeneration

(2016) Anne-Marie Miller et al.   Bioanalysis

Fit-for-purpose biomarker immunoassay qualification and validation: three case studies

(2016) Kyra Cowan et al.   Bioanalysis

Accuracy: a potential quandary in regulated bioanalysis of ‘endogenous’ analytes

(2016) Rand G Jenkins   Bioanalysis

Parallelism experiments in biomarker ligand-binding assays to assess immunological similarity

(2016) Lindsay E King   Bioanalysis

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

(2015) Darshana Jani et al.   AAPS Journal

Calculations for Adjusting Endogenous Biomarker Levels During Analytical Recovery Assessments for Ligand-Binding Assay Bioanalytical Method Validation

(2015) John F. Marcelletti et al.   AAPS Journal

Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development

(2015) Masood U Khan et al.   Bioanalysis

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

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

(2014) Brian Booth et al.   AAPS Journal

Interference in immunoassays to support therapeutic antibody development in preclinical and clinical studies

(2014) Martin Schwickart et al.   Bioanalysis

Protein-based matrix interferences in ligand-binding assays

(2014) Boris Gorovits et al.   Bioanalysis

Parallelism: considerations for the development, validation and implementation of PK and biomarker ligand-binding assays

(2014) Lauren F Stevenson et al.   Bioanalysis

Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

(2013) Lauren Stevenson et al.   AAPS Journal

What is going on with my samples? A general approach to parallelism assessment and data interpretation for biomarker ligand-binding assays

(2013) Shawn Ciotti et al.   Bioanalysis

Characterization of a multiplex, 12-biomarker test for rheumatoid arthritis

(2012) P. Scott Eastman et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

(2012) Binodh DeSilva et al.   Bioanalysis

Recommendations on biomarker bioanalytical method validation by GCC

(2012) Richard Hougton et al.   Bioanalysis

European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development

(2012) Philip Timmerman et al.   Bioanalysis

Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development

(2011) Jean W. Lee et al.   AAPS Journal

Accuracy and reproducibility of a multiplex immunoassay platform: A validation study

(2011) Julie A. Bastarache et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies

(2011) Marie-Anne Valentin et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs

(2010) J Cummings et al.   BRITISH JOURNAL OF CANCER

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

(2010) Jean W Lee   Bioanalysis

Systematic analytical validation of commercial kits for the determination of novel biomarkers for clinical drug development

(2010) William Nowatzke et al.   Bioanalysis

Novel approaches using alkaline or acid/guanidine treatment to eliminate therapeutic antibody interference in the measurement of total target ligand

(2009) Hossein Salimi-Moosavi et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Validation of Analytic Methods for Biomarkers Used in Drug Development

(2008) C. H. Chau et al.   CLINICAL CANCER RESEARCH

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

Insights in the application of research-grade diagnostic kits for biomarker assessments in support of clinical drug development: Bioanalysis of circulating concentrations of soluble receptor activator of nuclear factor κB ligand

(2008) Ronald R. Bowsher et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS