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)

Novel drug and soluble target tolerant antidrug antibody assay for therapeutic antibodies bearing the P329G mutation

(2017) Uwe Wessels et al.   Bioanalysis

Recommendations for clinical biomarker specimen preservation and stability assessments

(2017) Naveen Dakappagari et al.   Bioanalysis

Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics

(2016) Bonnie Wu et al.   AAPS Journal

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

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

Innovation in the pharmaceutical industry: New estimates of R&D costs

(2016) Joseph A. DiMasi et al.   JOURNAL OF HEALTH ECONOMICS

Validation of a ligand-binding assay for active protein drug quantification following the ‘free analyte QC concept’

(2016) Eginhard Schick 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

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS)

(2016) Eric Yang et al.   Bioanalysis

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies)

(2016) An Song et al.   Bioanalysis

Reduction of dilution error in ELISAs using an internal standard

(2016) Thorsten Verch et al.   Bioanalysis

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

(2016) Kyra Cowan et al.   Bioanalysis

Preanalytical Variables Affecting the Integrity of Human Biospecimens in Biobanking

(2015) C. Ellervik et al.   CLINICAL CHEMISTRY

A breakthrough novel method to resolve the drug and target interference problem in immunogenicity assays

(2015) Jad Zoghbi et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Anti-PEG antibody bioanalysis: a clinical case study with PEG-IFN-λ-1a and PEG-IFN-α2a in naive patients

(2015) Heather Myler et al.   Bioanalysis

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 – hybrid LBA/LCMS and input from regulatory agencies)

(2015) Brad Ackermann et al.   Bioanalysis

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS)

(2015) Jan Welink 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

Development of a Method That Eliminates False-Positive Results due to Nerve Growth Factor Interference in the Assessment of Fulranumab Immunogenicity

(2014) Sheng Dai et al.   AAPS Journal

Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations

(2014) G. Shankar et al.   AAPS Journal

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

(2014) Boris Gorovits et al.   JOURNAL OF IMMUNOLOGICAL METHODS

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS)

(2014) Eric Fluhler et al.   Bioanalysis

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)

(2014) Dawn Dufield et al.   Bioanalysis

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

(2014) Lauren Stevenson et al.   Bioanalysis

Immune responses to AAV vectors: overcoming barriers to successful gene therapy

(2013) F. Mingozzi et al.   BLOOD

A Survey on Data Reproducibility in Cancer Research Provides Insights into Our Limited Ability to Translate Findings from the Laboratory to the Clinic

(2013) Aaron Mobley et al.   PLoS One

2013 White Paper on recent issues in bioanalysis: ‘hybrid’ – the best of LBA and LCMS

(2013) Lauren Stevenson et al.   Bioanalysis

Stratification of Antibody-Positive Subjects by Antibody Level Reveals an Impact of Immunogenicity on Pharmacokinetics

(2012) Lei Zhou et al.   AAPS Journal

Correlation between anti-interferon-β binding and neutralizing antibodies in interferon-β-treated multiple sclerosis patients

(2012) P. E. H. Jensen et al.   EUROPEAN JOURNAL OF NEUROLOGY

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

(2012) Binodh DeSilva et al.   Bioanalysis

Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification

(2012) Roland F Staack et al.   Bioanalysis

Recommendations on biomarker bioanalytical method validation by GCC

(2012) Richard Hougton et al.   Bioanalysis

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

(2011) Fabio Garofolo et al.   Bioanalysis

Correlates of Protection Induced by Vaccination

(2010) S. A. Plotkin   Clinical and Vaccine Immunology

Fit-for-purpose biomarker method validation in anticancer drug development

(2010) Jeffrey Cummings et al.   DRUG DISCOVERY TODAY

Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies

(2010) Kay Stubenrauch et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Dystrophin Immunity in Duchenne's Muscular Dystrophy

(2010) Jerry R. Mendell et al.   NEW ENGLAND JOURNAL OF MEDICINE

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

(2010) Natasha Savoie et al.   Bioanalysis

The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

(2009) Natasha Savoie et al.   Bioanalysis

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

(2009) Natasha Savoie et al.   Bioanalysis

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

(2008) Eugen Koren et al.   JOURNAL OF IMMUNOLOGICAL METHODS