2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

Protein Biomarker Quantification by Immunoaffinity Liquid Chromatography–Tandem Mass Spectrometry: Current State and Future Vision

(2020) Hendrik Neubert et al.   CLINICAL CHEMISTRY

Pharmacokinetic Characterization and Tissue Distribution of Fusion Protein Therapeutics by Orthogonal Bioanalytical Assays and Minimal PBPK Modeling

(2020) Hiroshi Sugimoto et al.   MOLECULES

Multifaceted Bioanalytical Methods for the Comprehensive Pharmacokinetic and Catabolic Assessment of MEDI3726, an Anti-PSMA PBD Antibody-Drug Conjugate

(2020) Yue Huang et al.   ANALYTICAL CHEMISTRY

Characterization of therapeutic oligonucleotides by liquid chromatography

(2020) Alexandre Goyon et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

A Multiplexed HILIC-MS/HRMS Assay for the Assessment of Transporter Inhibition Biomarkers in Phase I Clinical Trials: Isobutyryl-Carnitine as an Organic Cation Transporter (OCT1) Biomarker

(2020) Lina Luo et al.   ANALYTICAL CHEMISTRY

An LC–MS/MS approach to assess total and free protein target in the serum of cynomolgus monkey

(2019) Hongmei Cao et al.   Bioanalysis

Gut Reactions: Breaking Down Xenobiotic–Microbiome Interactions

(2019) Gerard Clarke et al.   PHARMACOLOGICAL REVIEWS

A Long-Acting PYY3–36 Analog Mediates Robust Anorectic Efficacy with Minimal Emesis in Nonhuman Primates

(2019) Shamina M. Rangwala et al.   Cell Metabolism

Critical reagent screening and characterization: benefits and approaches for protein biomarker assays by hybrid LC–MS

(2019) Rasa Santockyte et al.   Bioanalysis

Determination of Real Time in Vivo Drug Receptor Occupancy for a Covalent Binding Drug as a Clinical Pharmacodynamic Biomarker by Immunocapture-LC-MS/MS

(2019) Naiyu Zheng et al.   ANALYTICAL CHEMISTRY

LC-MS bioanalysis of intact proteins and peptides

(2019) Lijuan Kang et al.   BIOMEDICAL CHROMATOGRAPHY

A sensitive antibody-free 2D-LC–MS/MS assay for the quantitation of myostatin in the serum of different species

(2019) Guodong Zhang et al.   Bioanalysis

An oligonucleotide bioanalytical LC–SRM methodology entirely liberated from ion-pairing

(2019) Robert MacNeill et al.   Bioanalysis

Insights from pharmacokinetic models of host-microbiome drug metabolism

(2019) Maria Zimmermann-Kogadeeva et al.   Gut Microbes

2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays (Part 1 – Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis)

(2019) Christine Fandozzi et al.   Bioanalysis

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

(2019) Brian Booth et al.   Bioanalysis

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

(2019) Steven Piccoli et al.   Bioanalysis

Mass spectrometric recommendations for Quan/Qual analysis using liquid-chromatography coupled to quadrupole time-of-flight mass spectrometry

(2018) Anne-Charlotte Dubbelman et al.   ANALYTICA CHIMICA ACTA

Top-down LC–MS quantitation of intact denatured and native monoclonal antibodies in biological samples

(2018) Liyun Zhang et al.   Bioanalysis

Quantitation of intact monoclonal antibody in biological samples: comparison of different data processing strategies

(2018) Xi Qiu et al.   Bioanalysis

Quantitation of Intact Proteins in Human Plasma Using Top-Down Parallel Reaction Monitoring-MS

(2018) Yuchao Chen et al.   ANALYTICAL CHEMISTRY

Salivary and Gut Microbiomes Play a Significant Role in in Vitro Oral Bioaccessibility, Biotransformation, and Intestinal Absorption of Arsenic from Food

(2018) Marta Calatayud et al.   ENVIRONMENTAL SCIENCE & TECHNOLOGY

High-Resolution Mass Spectrometry Quantification: Impact of Differences in Data Processing of Centroid and Continuum Data

(2018) L. Vereyken et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

2018 White Paper on Recent Issues in Bioanalysis: ‘A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)’ (Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

(2018) Jan Welink et al.   Bioanalysis

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

(2018) Lauren Stevenson et al.   Bioanalysis

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

(2018) Hendrik Neubert et al.   Bioanalysis

The impact of ion-pairing reagents on the selectivity and sensitivity in the analysis of modified oligonucleotides in serum samples by liquid chromatography coupled with tandem mass spectrometry

(2017) Sylwia Studzińska et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Assessing the Interplay between the Physicochemical Parameters of Ion-Pairing Reagents and the Analyte Sequence on the Electrospray Desorption Process for Oligonucleotides

(2017) Babak Basiri et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

Insights into the Proteome of Gastrointestinal Stromal Tumors-Derived Exosomes Reveals New Potential Diagnostic Biomarkers

(2017) Safinur Atay et al.   MOLECULAR & CELLULAR PROTEOMICS

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

The Decennial Index of the White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

(2017) Wei Garofolo et al.   Bioanalysis

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs)

(2017) Hendrik Neubert et al.   Bioanalysis

2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)

(2017) Jan Welink et al.   Bioanalysis

An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs

(2016) Prajakti A. Kothare et al.   AAPS Journal

Custom-Designed Affinity Capture LC-MS F(ab′)2 Assay for Biotransformation Assessment of Site-Specific Antibody Drug Conjugates

(2016) Dian Su et al.   ANALYTICAL CHEMISTRY

Validation of the Mass-Extraction-Window for Quantitative Methods Using Liquid Chromatography High Resolution Mass Spectrometry

(2016) Gaétan Glauser et al.   ANALYTICAL CHEMISTRY

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

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

A whole-molecule immunocapture LC–MS approach for the in vivo quantitation of biotherapeutics

(2016) John F Kellie et al.   Bioanalysis

Ontogeny of plasma proteins, albumin and binding of diazepam, cyclosporine and deltamethrin

(2015) Pankaj K. Sethi et al.   PEDIATRIC RESEARCH

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

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

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

(2013) Lauren Stevenson et al.   Bioanalysis

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

(2012) Binodh DeSilva et al.   Bioanalysis

Development of a bioanalytical method for quantification of a 15-mer oligonucleotide at sub-ng/ml concentrations using LC–MS/MS

(2012) Martyn Hemsley et al.   Bioanalysis

Higher clearance of micafungin in neonates compared with adults: role of age-dependent micafungin serum binding

(2011) Souzan B. Yanni et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Targeted quantitative bioanalysis in plasma using liquid chromatography/high-resolution accurate mass spectrometry: an evaluation of global selectivity as a function of mass resolving power and extraction window, with comparison of centroid and profile mo

(2011) Yuan-Qing Xia et al.   RAPID COMMUNICATIONS IN MASS SPECTROMETRY

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

(2011) Fabio Garofolo et al.   Bioanalysis

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

(2010) Natasha Savoie et al.   Bioanalysis

Drug Development for Pediatric Populations: Regulatory Aspects

(2010) Jochen Zisowsky et al.   Pharmaceutics

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