Bioanalysis

Article	Citations
Flow cytometry: principles, applications and recent advances	52
Validation of dried blood spot sample modifications to two commercially available COVID-19 IgG antibody immunoassays	42
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 – Recommen	32
A novel, robust method for quantification of multiple kynurenine pathway metabolites in the cerebrospinal fluid	28
Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA	27
Optimization and validation of a microcolony multiplexed opsonophagocytic killing assay for 15 pneumococcal serotypes	27
Detection of SARS-CoV-2 at the point of care	25
Exhaled breath condensate as a potential specimen for diagnosing COVID-19	24
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 Indust	24
Virtual drug testing: redefining sample collection in a global pandemic	23
Cytochrome P450 enzymes: a review on drug metabolizing enzyme inhibition studies in drug discovery and development	21
Microsampling and LC–MS/MS for antidoping testing of glucocorticoids in urine	21
Assessment of low volume sampling technologies: utility in nonclinical and clinical studies	20
Dried blood spots in doping analysis	20
Clinical application of volumetric absorptive microsampling to the gefapixant development program	19
Green bioanalytical sample preparation: fabric phase sorptive extraction	19
Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis	19
Determination of favipiravir in human plasma using homogeneous liquid–liquid microextraction followed by HPLC/UV	18
Use of capillary dried blood for quantification of intact IGF-I by LC–HRMS for antidoping analysis	16
Bottom-up sample preparation for the LC–MS/MS quantification of anti-cancer monoclonal antibodies in bio matrices	16
Could breath analysis by MS could be a solution to rapid, non-invasive testing for COVID-19?	16
Separation-free spectrophotometric platforms for rapid assessment of combined antiplatelet therapy in complex matrices	15
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A – Recommendations on Biotherapeu	15
Precision multiparameter tracking of inflammation on timescales of hours to years using serial dried blood spots	15
Development and validation of an UHPLC–MS/MS method for extended serum steroid profiling in female populations	15

How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in bioanalysis	14
Automation of RNA-based biomarker extraction from dried blood spots for the detection of blood doping	14
Assessing the impact of nonspecific binding on oligonucleotide bioanalysis	14
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Ma	13
Recommendations on qPCR/ddPCR assay validation by GCC	13
Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice	12
Kidney transplant recipient’s perceptions of blood testing through microsampling and venepuncture	12
Development of a LC–MS/MS method for the quantification of toxic payload DM1 cleaved from BT1718 in a Phase I study	12
Evaluation, identification and impact assessment of abnormal internal standard response variability in regulated LC−MS bioanalysis	12
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability &	12
Gene doping and genomic science in sports: where are we?	11
Rapid development of analytical methods for evaluating pandemic vaccines: a COVID-19 perspective	11
Considerations in the development and validation of real-time quantitative polymerase chain reaction and its application in regulated bioanalysis to characterize the cellular kinetics of CAR-T product	11
Electromembrane extraction of peptides and amino acids – status and perspectives	11
Validation and clinical application of a volumetric absorptive microsampling method for 14 psychiatric drugs	11
Validation and application of hybridization liquid chromatography-tandem mass spectrometry methods for quantitative bioanalysis of antisense oligonucleotides	11
Biomarkers of doping: uses, discovery and validation	11
LC–MS/MS bioanalytical method for quantification of binimetinib and venetoclax, and their pharmacokinetic interaction	10
A whole blood microsampling assay for vancomycin: development, validation and application for pediatric clinical study	10
Application of microextraction techniques in alternative biological matrices with focus on forensic toxicology: a review	10
Quantitation of 2-hydroxyglutarate in human plasma via LC–MS/MS using a surrogate analyte approach	10
Volumetric absorptive microsampling: its use in COVID-19 research and testing	10
Accelerating protein biomarker discovery and translation from proteomics research for clinical utility	10
Enantiomeric analysis of clenbuterol in Chinese people by LC–MS/MS to distinguish doping abuse from meat contamination	10
A low-voltage electro-membrane extraction for quantification of imatinib and sunitinib in biological fluids	10
A minireview on nanoparticle-based sensors for the detection of coronaviruses	10
Glycoproteomic bioanalysis of exosomes by LC–MS for early diagnosis of pancreatic cancer	10
European Bioanalysis Forum recommendation on singlicate analysis for ligand binding assays: time for a new mindset	10
Analytical method validation for biomarkers as a drug development tool: points to consider	9
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Par	9
A flow cytometric journey into cell cycle analysis	9
The development of patient-centric sampling as an enabling technology for clinical trials	9
Metabolomics and doping analysis: promises and pitfalls	9
In vitro testing of the hemaPEN microsampling device for the quantification of acetaminophen in human blood	9
With great power comes great responsibility: high-dimensional spectral flow cytometry to support clinical trials	9
The role of ligand-binding assay and LC–MS in the bioanalysis of complex protein and oligonucleotide therapeutics	9
Giving patients choices: AstraZeneca’s evolving approach to patient-centric sampling	9
Toward comparability of anti-drug antibody assays: is the amount of anti-drug antibody–reagent complexes at cut-point (CP-ARC) the missing piece?	8
Development of a bioanalytical method for an antisense therapeutic using high-resolution mass spectrometry	8
Quantification of abemaciclib and metabolites: evolution of bioanalytical methods supporting a novel oncolytic agent	8
Recent bionalytical methods for the determination of new psychoactive substances in biological specimens	8
Determination of levofloxacin by HPLC with fluorescence detection in human breast milk	8
Quantification of fat-soluble vitamins and their metabolites in biological matrices: an updated review	8
Validation of enantioseparation and quantitation of an active metabolite of abrocitinib in human plasma	8
Evaluation of correlation between bioanalytical methods	8
Therapeutic drug monitoring of polymyxin B by LC–MS/MS in plasma and urine	8
Laboratory considerations amidst the coronavirus disease 2019 outbreak: the Spedali Civili in Brescia experience	8
A brief history of the development of a gene doping test	8
Pharmacokinetic drug–drug interactions: an insight into recent US FDA-approved drugs for prostate cancer	7
A robust LC–MS/MS method for amikacin: application to cellular uptake and pharmacokinetic studies	7

Sample preparation in capillary electrophoresis for the determination of small molecule drugs and metabolites in urine	7
Assessment of clinically relevant immunogenicity for mAbs; are we over reporting ADA?	7
pH-induced homogeneous liquid–liquid microextraction method based on new switchable deep eutectic solvent for the extraction of three antiepileptic drugs from breast milk	7
Overcoming multimeric target interference in a bridging immunogenicity assay with soluble target receptor, target immunodepletion and mild acidic assay pH	7
Intact mAb LC–MS for drug concentration from pre-clinical studies: bioanalytical method performance and in-life samples	7
Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum	7
Patient-centric sampling special focus issue	7
Quantitation of ivosidenib in human plasma via LC–MS/MS and its application in clinical trials	7
Analytical comparison of ELISA and mass spectrometry for quantification of serum hepcidin in critically ill patients	6
Quantification of infliximab and adalimumab in human plasma by a liquid chromatography tandem mass spectrometry kit and comparison with two ELISA methods	6
A novel hydrophilic interaction chromatography assay characterization of 4-pyridoxic acid, an emergent renal organic anion transporter 1/3 transporter biomarker	6
Analysis of biofluids by paper spray-MS in forensic toxicology	6
Novel hydrophilic-phase extraction, HILIC and high-resolution MS quantification of an RNA oligonucleotide in plasma	6
Recent advances in chiral analysis for biosamples in clinical research and forensic toxicology	6
Sensors and microarrays in protein biomarker monitoring: an electrochemical perspective spots	6
Challenges and recommendations in developing LC–MS/MS bioanalytical assays of labile glucuronides and parent compounds in the presence of glucuronide metabolites	6
Less is more: an ecological and economic point of view on appropriate use of lab testing for COVID-19 patients	6
Solutions for hematocrit bias in dried blood spot hormone analysis	6
Rapid diagnostics for SARS-CoV-2 virus: point-of-care testing and lessons learned during the pandemic	6
Adaptation of Elecsys® anti-severe acute respiratory syndrome coronavirus-2 immunoassay to dried blood spots: proof of concept	6
Analytical and bioanalytical HPLC method for simultaneous estimation of 5-fluorouracil and sonidegib	6
Validation of high-throughput, semiquantitative solid-phase SARS coronavirus-2 serology assays in serum and dried blood spot matrices	6
A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum	6
Biopharmaceutical quality control with mass spectrometry	5
Comparison of three parallelism assessment methods of biomarker quantification by LC-MS/MS: a case study of the bioanalysis of creatinine in human urine samples	5
Psychoactive substances in human breast milk: a review of analytical strategies for their investigation	5
Bioanalysis and the oncology revolution	5
Using multiple platforms for critical reagents selection process to support pharmacokinetic ligand-binding assay development	5
Hybrid LC–MS as a powerful tool for supporting protein bioanalysis in gene and cell therapies	5
Novel bioanalytical method for the characterization of the immune response directed against a bispecific F(ab) fragment	5
Analytical considerations for reducing the matrix effect for the sphingolipidome quantification in whole blood	5
Understanding quantitative polymerase chain reaction bioanalysis issues before validation planning: Japan Bioanalysis Forum discussion group	5
Quantification of antibody–drug conjugate PYX-201 in rat and monkey plasma via ELISA and its application in preclinical studies	5
Flow cytometry and pharmacokinetics	5
Chromatographic estimation of a novel triple-therapy combination targeting Helicobacter pylori eradication in different matrices	5
Validation of an LC–MS/MS method for the determination of sotorasib, a KRASG12C inhibitor, in human plasma	5
Progress towards global standardization for quantitative flow cytometry	5
Quantitation of capmatinib, a mesenchymal-epithelial transition factor inhibitor by UPLC–MS/MS in rat plasma and its application to a pharmacokinetic study	5
Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis	5
Recommendations on ELISpot assay validation by the GCC	5
Flow-based method for the determination of biomarkers urea and ammoniacal nitrogen in saliva	5
Lessons learned from the COVID-19 pandemic and its impact on bioanalysis and drug development	5
Review onin vivoprofiling of drug metabolites with LC-MS/MS in the past decade	5
Characterization of robust immune responses to a bispecific antibody, a novel class of antibody therapeutics	5
Selection of a surrogate matrix for the quantification of an endogenous analyte in dried whole blood	5
The importance of quality critical reagents for the entire developmental lifecycle of a biopharmaceutical: a pharmacokinetic case study	4
US FDA-validated green GC–MS method for analysis of gabapentin, tramadol and/or amitriptyline mixtures in biological fluids	4
Microflow LC–MS/MS to improve sensitivity for antisense oligonucleotides bioanalysis: critical role of sample cleanness	4
A guided approach to preclinical bioanalysis of proteins using immunoassays for pharmacokinetic and pharmacodynamic assessments	4
Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device	4
Critical reagent characterization and re-evaluation to ensure long-term stability: two case studies	4
Advancements in practical and scientific bioanalytical approaches to metabolism studies in drug development	4
Comparing singlet and duplicate immunogenicity assay in human plasma for pembrolizumab using Gyrolab®	4
A peptide immunoaffinity LC–MS/MS strategy for quantifying the GPCR protein, S1PR1 in human colon biopsies	4
Introducing dendritic cell antibody internalization as an immunogenicity risk assessment tool	4
Metabolism of steroids and sport drug testing	4
Simultaneous determination of canrenone, digoxin and tolvaptan by UHPLC–MS/MS: application in heart failure patients	4
Quantification of a promising JNK inhibitor and nitrovasodilator IQ-1 and its major metabolite in rat plasma by LC–MS/MS	4
Criteria of slope and endogenous level for selection of matrix in the quantitation of endogenous compounds by LC-MS/MS	4
LC–MS/MS assays to quantify sulfatides and lysosulfatide in cerebrospinal fluid of metachromatic leukodystrophy patients	4
REGEN-COV® antibody cocktail bioanalytical strategy: comparison of LC-MRM-MS and immunoassay methods for drug quantification	4
Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests	4
Novel sequential immunocapture microflow LC/MS/MS approach to measuring PTH-Fc protein in human serum	3
UHPLC–MS/MS method for iohexol determination in human EDTA and lithium-heparin plasma, human urine and in goat- and pig EDTA plasma	3
Bioanalysis of tucatinib and metabolite, and a five-way cross-validation to support clinical pharmacokinetic analysis	3
Preclinical pharmacokinetics of 4-hydroxy isoleucine using LC–MS/MS: a potential polycystic ovary syndrome phytopharmaceutical therapeutics	3
Efficiency of pooled surveillance testing in academic labs to detect and inhibit COVID-19 outbreaks	3
Statistical methods of screening cut point determination in immunogenicity studies	3
Green bioanalysis: an innovative and eco-friendly approach for analyzing drugs in biological matrices	3
HPLC method for simultaneous estimation of paclitaxel and baicalein: pharmaceutical and pharmacokinetic applications	3
Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control	3
Native high-resolution mass spectrometry analysis of noncovalent protein complexes up to 450 kDa	3
SFC-MS/MS method for simultaneous determination of nimodipine and 3-n-butylphthalide in beagle plasma: application to pharmacokinetic interaction study	3
HPLC–MS/MS studies of brimonidine in rabbit aqueous humor by microdialysis	3
Innovation in bioanalytical strategies and in vitro drug–drug interaction study approaches in drug discovery	3
Immunoaffinity LC–MS/MS is more suitable than ELISA to quantify a PEGylated molecule in cynomolgus monkey serum	3
Bioanalytical strategy for the characterization and bioanalysis of biologics: a global, nonregulated bioanalytical lab perspective	3
Feasibility of singlicate-based analysis in bridging ADA assay on Meso-Scale Discovery platform: comparison with duplicate analysis	3
Determination of cortisol in hair using liquid chromatography-tandem mass spectrometry: a short review	3
A cell-based FcRn-dependent recycling assay for predictive pharmacokinetic assessment of therapeutic antibodies	3

Cloud solutions for GxP laboratories: considerations for data storage	3
A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects	3
European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period	3
The impact of ligand binding based assays critical reagent characterization and storage	3
Evaluation of two point of care technologies for measuring monoclonal antibody therapeutic-A concentrations in blood	3
Bioanalytical research and training in academia during the COVID-19 pandemic	3
Safety considerations in the bioanalytical laboratories handling specimens from coronavirus disease 2019 patients	3
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Par	3
High-sensitivity quantification of antisense oligonucleotides for pharmacokinetic characterization	3
COVID-19’s impact on bioanalytical labs	3
Nontargeted fecal metabolomics: an emerging tool to probe the role of the gut microbiome in host health	3
Critical reagent generation, characterization, handling and storage workflows: impact on ligand binding assays	3
A multilaboratory validation study of LC/MS biomarker assays for three lysophosphatidylcholines	3
Capillary microsampling in clinical studies: opportunities and challenges in two case studies	3
Monitoring of hemoglobin and erythropoiesis-related mRNA with dried blood spots in athletes and patients	3
Strategies to develop highly drug-tolerant cell-based neutralizing antibody assay: neutralizing antidrug antibodies extraction and drug depletion	3
High-sensitivity workflow for LC–MS-based analysis of GalNAc-conjugated oligonucleotides: a case study	3
In vitroimmunogenicity prediction: bridging between innate and adaptive immunity	3
Validation and clinical application of dried blood spot assay for quantitative assessment of edoxaban in healthy adults	3
Analysis of 14 drugs in dried blood microsamples in a single workflow using whole blood and serum calibrators	3
Fluispotter, a novel automated and wearable device for accurate volume serial dried blood spot sampling	3
Applications of supercritical fluid chromatography technique in current bioanalysis and pharmaceutical analysis	3
Chemical derivatization in combination with supercritical fluid chromatography to improve resolution of stereoisomers	3
Outcomes of adverse analytical findings in individual and team sports	3
Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein–MS from the 2021 European Bioanalysis Forum Focus Workshops	3
Managing bioanalytical studies during the COVID-19 pandemic: an overview	3
Method development for the quantification of lead levels in whole blood sampled on Mitra® with VAMS® tips by inductively coupled plasma–MS/MS	3
The analysis of acetaminophen (paracetamol) and seven metabolites in rat, pig and human plasma by U(H)PLC–MS	3