Bioanalysis

Article	Citations
Flow cytometry: principles, applications and recent advances	55
Validation of dried blood spot sample modifications to two commercially available COVID-19 IgG antibody immunoassays	45
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
Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA	29
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	26
Exhaled breath condensate as a potential specimen for diagnosing COVID-19	24
Virtual drug testing: redefining sample collection in a global pandemic	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
Microsampling and LC–MS/MS for antidoping testing of glucocorticoids in urine	22
Assessment of low volume sampling technologies: utility in nonclinical and clinical studies	22
Cytochrome P450 enzymes: a review on drug metabolizing enzyme inhibition studies in drug discovery and development	22
Green bioanalytical sample preparation: fabric phase sorptive extraction	21
Determination of favipiravir in human plasma using homogeneous liquid–liquid microextraction followed by HPLC/UV	20
Dried blood spots in doping analysis	20
Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis	19
Clinical application of volumetric absorptive microsampling to the gefapixant development program	19
Bottom-up sample preparation for the LC–MS/MS quantification of anti-cancer monoclonal antibodies in bio matrices	17
Use of capillary dried blood for quantification of intact IGF-I by LC–HRMS for antidoping analysis	17
Could breath analysis by MS could be a solution to rapid, non-invasive testing for COVID-19?	16
Development and validation of an UHPLC–MS/MS method for extended serum steroid profiling in female populations	15
Precision multiparameter tracking of inflammation on timescales of hours to years using serial dried blood spots	15
Automation of RNA-based biomarker extraction from dried blood spots for the detection of blood doping	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
How the COVID-19 pandemic is changing clinical trial conduct and driving innovation in 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	14
Assessing the impact of nonspecific binding on oligonucleotide bioanalysis	14
Validation and clinical application of a volumetric absorptive microsampling method for 14 psychiatric drugs	13
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 &	13
Recommendations on qPCR/ddPCR assay validation by GCC	13
With great power comes great responsibility: high-dimensional spectral flow cytometry to support clinical trials	13
Validation and application of hybridization liquid chromatography-tandem mass spectrometry methods for quantitative bioanalysis of antisense oligonucleotides	13
Gene doping and genomic science in sports: where are we?	12
A low-voltage electro-membrane extraction for quantification of imatinib and sunitinib in biological fluids	12
Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice	12
Rapid development of analytical methods for evaluating pandemic vaccines: a COVID-19 perspective	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
Biomarkers of doping: uses, discovery and validation	11
Electromembrane extraction of peptides and amino acids – status and perspectives	11
A whole blood microsampling assay for vancomycin: development, validation and application for pediatric clinical study	11
A flow cytometric journey into cell cycle analysis	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
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
Analytical method validation for biomarkers as a drug development tool: points to consider	10
Quantification of fat-soluble vitamins and their metabolites in biological matrices: an updated review	10
Metabolomics and doping analysis: promises and pitfalls	10
The role of ligand-binding assay and LC–MS in the bioanalysis of complex protein and oligonucleotide therapeutics	10
Volumetric absorptive microsampling: its use in COVID-19 research and testing	10
Glycoproteomic bioanalysis of exosomes by LC–MS for early diagnosis of pancreatic cancer	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
LC–MS/MS bioanalytical method for quantification of binimetinib and venetoclax, and their pharmacokinetic interaction	10
A minireview on nanoparticle-based sensors for the detection of coronaviruses	10
Determination of levofloxacin by HPLC with fluorescence detection in human breast milk	9
A brief history of the development of a gene doping test	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
Giving patients choices: AstraZeneca’s evolving approach to patient-centric sampling	9
The development of patient-centric sampling as an enabling technology for clinical trials	9
In vitro testing of the hemaPEN microsampling device for the quantification of acetaminophen in human blood	9
Recent bionalytical methods for the determination of new psychoactive substances in biological specimens	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
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
Challenges and recommendations in developing LC–MS/MS bioanalytical assays of labile glucuronides and parent compounds in the presence of glucuronide metabolites	8
Validation of enantioseparation and quantitation of an active metabolite of abrocitinib in human plasma	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
Rapid diagnostics for SARS-CoV-2 virus: point-of-care testing and lessons learned during the pandemic	7
Review onin vivoprofiling of drug metabolites with LC-MS/MS in the past decade	7
Patient-centric sampling special focus issue	7
Novel hydrophilic-phase extraction, HILIC and high-resolution MS quantification of an RNA oligonucleotide in plasma	7
A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum	7
Adaptation of Elecsys® anti-severe acute respiratory syndrome coronavirus-2 immunoassay to dried blood spots: proof of concept	7

Assessment of clinically relevant immunogenicity for mAbs; are we over reporting ADA?	7
Analytical and bioanalytical HPLC method for simultaneous estimation of 5-fluorouracil and sonidegib	7
Less is more: an ecological and economic point of view on appropriate use of lab testing for COVID-19 patients	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
Quantification of infliximab and adalimumab in human plasma by a liquid chromatography tandem mass spectrometry kit and comparison with two ELISA methods	7
Applying context of use to quantitative polymerase chain reaction method validation and analysis: a recommendation from the European Bioanalysis Forum	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
Sample preparation in capillary electrophoresis for the determination of small molecule drugs and metabolites in urine	7
Quantitation of ivosidenib in human plasma via LC–MS/MS and its application in clinical trials	7
Recent advances in chiral analysis for biosamples in clinical research and forensic toxicology	7
Pharmacokinetic drug–drug interactions: an insight into recent US FDA-approved drugs for prostate cancer	7
Validation of high-throughput, semiquantitative solid-phase SARS coronavirus-2 serology assays in serum and dried blood spot matrices	6
Recommendations on ELISpot assay validation by the GCC	6
Analysis of biofluids by paper spray-MS in forensic toxicology	6
Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis	6
Solutions for hematocrit bias in dried blood spot hormone analysis	6
Analytical comparison of ELISA and mass spectrometry for quantification of serum hepcidin in critically ill patients	6
Microflow LC–MS/MS to improve sensitivity for antisense oligonucleotides bioanalysis: critical role of sample cleanness	6
Sensors and microarrays in protein biomarker monitoring: an electrochemical perspective spots	6
A novel hydrophilic interaction chromatography assay characterization of 4-pyridoxic acid, an emergent renal organic anion transporter 1/3 transporter biomarker	6
Analytical considerations for reducing the matrix effect for the sphingolipidome quantification in whole blood	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
Lessons learned from the COVID-19 pandemic and its impact on bioanalysis and drug development	5
Psychoactive substances in human breast milk: a review of analytical strategies for their investigation	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
Biopharmaceutical quality control with mass spectrometry	5
Quantification of antibody–drug conjugate PYX-201 in rat and monkey plasma via ELISA and its application in preclinical studies	5
Chromatographic estimation of a novel triple-therapy combination targeting Helicobacter pylori eradication in different matrices	5
Using multiple platforms for critical reagents selection process to support pharmacokinetic ligand-binding assay development	5
Characterization of robust immune responses to a bispecific antibody, a novel class of antibody therapeutics	5
HPLC method for simultaneous estimation of paclitaxel and baicalein: pharmaceutical and pharmacokinetic applications	5
Understanding quantitative polymerase chain reaction bioanalysis issues before validation planning: Japan Bioanalysis Forum discussion group	5
Flow cytometry and pharmacokinetics	5
Bioanalysis and the oncology revolution	5
Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device	5
Hybrid LC–MS as a powerful tool for supporting protein bioanalysis in gene and cell therapies	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
Innovation in bioanalytical strategies and in vitro drug–drug interaction study approaches in drug discovery	4
Statistical methods of screening cut point determination in immunogenicity studies	4
A guided approach to preclinical bioanalysis of proteins using immunoassays for pharmacokinetic and pharmacodynamic assessments	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
A cell-based FcRn-dependent recycling assay for predictive pharmacokinetic assessment of therapeutic antibodies	4
A survey of pharmacokinetic bioanalytical methods in biosimilar biological license applications for the assessment of target and antidrug antibody effects	4
In vitroimmunogenicity prediction: bridging between innate and adaptive immunity	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
High-sensitivity quantification of antisense oligonucleotides for pharmacokinetic characterization	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
Preclinical pharmacokinetics of 4-hydroxy isoleucine using LC–MS/MS: a potential polycystic ovary syndrome phytopharmaceutical therapeutics	4
Critical reagent characterization and re-evaluation to ensure long-term stability: two case studies	4
Challenges with development of a pharmacokinetics assay to measure a variably glycosylated fusion protein	4
Fluispotter, a novel automated and wearable device for accurate volume serial dried blood spot sampling	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
Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography–tandem mass spectrometry	4
LC–MS/MS assays to quantify sulfatides and lysosulfatide in cerebrospinal fluid of metachromatic leukodystrophy patients	4
Metabolism of steroids and sport drug testing	4
High-sensitivity workflow for LC–MS-based analysis of GalNAc-conjugated oligonucleotides: a case study	4
Simultaneous determination of canrenone, digoxin and tolvaptan by UHPLC–MS/MS: application in heart failure patients	4
Monitoring of hemoglobin and erythropoiesis-related mRNA with dried blood spots in athletes and patients	4
Strategies to develop highly drug-tolerant cell-based neutralizing antibody assay: neutralizing antidrug antibodies extraction and drug depletion	3
Applications of supercritical fluid chromatography technique in current bioanalysis and pharmaceutical analysis	3
Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy	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
Native high-resolution mass spectrometry analysis of noncovalent protein complexes up to 450 kDa	3
Safety considerations in the bioanalytical laboratories handling specimens from coronavirus disease 2019 patients	3
Green bioanalysis: an innovative and eco-friendly approach for analyzing drugs in biological matrices	3
HPLC–MS/MS studies of brimonidine in rabbit aqueous humor by microdialysis	3
Direct bioanalysis or indirect calculation of target engagement and free drug exposure: do we apply double standards?	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
A multilaboratory validation study of LC/MS biomarker assays for three lysophosphatidylcholines	3
Technological advancement in dry blood matrix microsampling and its clinical relevance in quantitative drug analysis	3
Bioanalysis of tucatinib and metabolite, and a five-way cross-validation to support clinical pharmacokinetic analysis	3

Microsampling in pediatric studies: pharmacokinetic sampling for baricitinib (Olumiant™) in global pediatric studies	3
Efficiency of pooled surveillance testing in academic labs to detect and inhibit COVID-19 outbreaks	3
SFC-MS/MS method for simultaneous determination of nimodipine and 3-n-butylphthalide in beagle plasma: application to pharmacokinetic interaction study	3
Chromatographic analysis of ciprofloxacin and metronidazole in real human plasma: green analytical chemistry perspective	3
Analysis of 14 drugs in dried blood microsamples in a single workflow using whole blood and serum calibrators	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
Outcomes of adverse analytical findings in individual and team sports	3
Dispersive liquid–liquid microextraction of 11-nor-Δ9-tetrahydrocannabinol-carboxylic acid applied to urine testing	3
COVID-19’s impact on bioanalytical labs	3
Immunoaffinity LC–MS/MS is more suitable than ELISA to quantify a PEGylated molecule in cynomolgus monkey serum	3
Critical reagent generation, characterization, handling and storage workflows: impact on ligand binding assays	3
Nitrosamine impurities: from raw materials to final drug product	3
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
Cloud solutions for GxP laboratories: considerations for data storage	3
Bioanalytical research and training in academia during the COVID-19 pandemic	3
Development of a specific immunoassay to selectively measure active tryptase in airway samples	3
Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein–MS from the 2021 European Bioanalysis Forum Focus Workshops	3
Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum	3
Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control	3
Solid-phase microextraction for assessment of plasma protein binding, a complement to rapid equilibrium dialysis	3
Uncovering the green frontier: harnessing deep eutectic solvents for sustainable bioanalysis	3
Chemical derivatization in combination with supercritical fluid chromatography to improve resolution of stereoisomers	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
Determination of morphine and its metabolites in the biological samples: an updated review	3
Capillary microsampling in clinical studies: opportunities and challenges in two case studies	3
Determination of cortisol in hair using liquid chromatography-tandem mass spectrometry: a short review	3
A smartphone digital image colorimetric method based on nanoparticles for determination of lamotrigine	3