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

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

(2015) Darshana Jani et al.   AAPS Journal

Transient and Persistent Antibodies Against TNF-Inhibitors in IBD

(2015) Casper Steenholdt   AMERICAN JOURNAL OF GASTROENTEROLOGY

Beyond peptides and mAbs-current status and future perspectives for biotherapeutics with novel constructs

(2015) Dalal AlDeghaither et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development

(2015) Lynette Brown et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Implementation of highly sophisticated flow cytometry assays in multicenter clinical studies: considerations and guidance

(2015) Ulrike Sommer et al.   Bioanalysis

When close is not close enough: a comparison of endogenous and recombinant biomarker stability samples

(2015) Stephanie Fraser et al.   Bioanalysis

Quantification of a bifunctional drug in the presence of an immune response: a ligand-binding assay specific for ‘active’ drug

(2015) Roland F Staack et al.   Bioanalysis

Proposal for a harmonized descriptive analyte nomenclature for quantitative large-molecule bioanalysis

(2015) Julia Heinrich 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

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

(2014) Joseph C. Marini 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

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

Due diligence in the characterization of matrix effects in a total IL-13 Singulex™ method

(2014) Stephanie Fraser 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

Recommendations on incurred sample stability (ISS) by GCC

(2014) Steve Lowes et al.   Bioanalysis

Validation of cell-based fluorescence assays: Practice guidelines from the ICSH and ICCS - part III - analytical issues

(2013) Shabnam Tanqri et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

Determination of optimal replicate number for validation of imprecision using fluorescence cell-based assays: Proposed practical method

(2013) Bruce H. Davis et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part II - preanalytical issues

(2013) Bruce H. Davis et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

Validation of cell-based fluorescence assays: Practice guidelines from the ICSH and ICCS - part V - assay performance criteria

(2013) Brent Wood et al.   CYTOMETRY PART B-CLINICAL CYTOMETRY

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

Flow cytometry: a flexible tool for biomarker research

(2012) Ruth M Barnard   Bioanalysis

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

Model-based strategy for bioanalytical method comparison: Measurement of a soluble ligand as a biomarker

(2011) Theingi M. Thway et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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

(2011) Fabio Garofolo et al.   Bioanalysis

Bispecific Antibodies for Cancer Immunotherapy

(2010) Dafne Müller et al.   BIODRUGS

Recommendations for the validation of flow cytometric testing during drug development: I instrumentation

(2010) Cherie L. Green et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Recommendations for the validation of flow cytometric testing during drug development: II assays

(2010) Denise M. O'Hara et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics

(2010) Deborah Finco et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Bispecific antibodies for cancer therapy

(2010) Patrick Chames et al.   mAbs

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

(2010) Natasha Savoie et al.   Bioanalysis

Development and validation of flow cytometry methods for pharmacodynamic clinical biomarkers

(2010) Dianna Y Wu et al.   Bioanalysis

Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies

(2009) Rafael Ponce et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

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

(2009) Natasha Savoie et al.   Bioanalysis

Ligand-binding assays: risk of using a platform supported by a single vendor

(2009) Jennifer Yohrling   Bioanalysis

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

(2009) Natasha Savoie et al.   Bioanalysis