OOIR: Observatory of International Research

Papers

(The TQCC of Bioanalysis is 3. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2021-01-01 to 2025-01-01.)

Article	Citations
Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum	65
Evaluation of hemaPEN ^® sampling device for measurement of cocaine and metabolites in capillary blood by LC-MS/MS	37
Quantitation of Ivosidenib in Human Plasma Via LC–MS/MS and its Application in Clinical Trials	27
Volumetric Absorptive Microsampling as An Effective Microsampling Technique for LC–MS/MS Bioanalysis of Biomarkers in Drug Discovery	26
Assay pH and Critical Reagent Optimization in Measuring Concentrations of a Monoclonal Antibody and its Target	26
Development, validation and application of a liquid chromatography–tandem mass spectrometry method for quantifying lurasidone in dried blood spot samples	25
Greenness assessment of microextraction techniques in therapeutic drug monitoring	24
Covalent organic frameworks: spotlight on applications in the pharmaceutical arena	24
Sample Preparation in Capillary Electrophoresis for the Determination of Small Molecule Drugs and Metabolites in Urine	22
Critical reagent considerations for immunogenicity assay development for bispecific biotherapeutic candidates	21
Two decades of immunocapture liquid chromatography tandem mass spectrometry for pharmaceutical discovery and development: reflections and recommendations for optimal deployment	21
Good Clinical Practices in the Bioanalytical Laboratory	20
Comparative pharmacokinetic study of Anisodamine Hydrobromide tablets and injection in septic acute lung injury rats	18
Rapid Development of Analytical Methods for Evaluating Pandemic Vaccines: A Covid-19 Perspective	17
Single-Analyte Biomarker Assays for Pharmacodynamic or Safety Assessment During Biotherapeutic Development	17
Biomonitoring of Arsenic, Lead, Manganese and Mercury in Hair from a Presumably Exposed Uruguayan Child Population	15
A Blood-Based, Metabolite and Demographic Characteristic Markers Panel For The Diagnosis of Alzheimer's Disease	15
LC–MS/MS Methods for Direct Measurement of Sepiapterin and Tetrahydrobiopterin in Human Plasma and Clinical Applications	15
Achieving Routine Application of Dried Blood Spots for Erythropoietin Receptor Agonist Analysis in Doping Control: Low-Volume Single-Spot Detection at Minimum Required Performance Level	14
Decentralized Clinical Trial Design Using Blood Microsampling Technology for Serum Bioanalysis	14
Calprotectin as a Biomarker in Rheumatoid Arthritis: The Potential Predictive Value of Response to Treatment	14
In Vitro Immunogenicity Prediction: Bridging between Innate and Adaptive Immunity	14
Challenges of Implementing Ultrahigh-Throughput Mass Spectrometry in Absorption, Distribution, Metabolism and Excretion Bioanalysis	14
Empowering Peptidomics: Utilizing Computational Tools and Approaches	13
In Vitro Study and Pharmacokinetic Evaluation of Sitagliptin Phosphate Enantiomers in Rat Plasma	13

Immunocapture LC–MS(/MS) Assays for Biotherapeutic and Biomarker Proteins: The European Bioanalysis Forum Continuing Discussions on Scientific and Regulatory Challenges	13
Digital Image Colorimetry for Determination of Ethanol in Exhaled Breath Condensate	13
LC–MS Bioanalysis of Protein Biomarkers and Protein Therapeutics in Formalin-Fixed Paraffin-Embedded Tissue Specimens	13
Application of a new volumetric microsampling device for quantitative bioanalysis of immunosuppression	11
Meet the Editorial Board – An Interview with Min Meng and Transitions from Small Regional Labs to Global CRO	11
Application of Novel Plasma Separation Filter Cards for Quantification of Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Di/Triphosphates in Dried Blood Spots Using Lc–Ms	11
Free Hemoglobin Determination at Patients’ Bedside to Evaluate Hemolysis	11
Prediction of frozen virus stability based on degradation mechanisms, real-time data and modeling	10
Bioanalysis of INCB000928 in hemodialysate: prevention of nonspecific binding and validation of surrogate matrices	10
Multidimensional Chromatography Platforms: Status and Prospects	9
An Ultrasensitive LC–MS/MS Method and Application to Clinical Dose-Range Finding for Glycopyrrolate via an e-Nebulizer	9
Novel Techniques and the New Age of Biomarkers: Panel Discussion Report	9
Feedback from the Sixth European Bioanalysis Forum Young Scientist Symposium	9
Innovation in Bioanalytical Strategies and in vitro Drug–drug Interaction Study Approaches in Drug Discovery	9
Validation of High-Throughput, Semiquantitative Solid-Phase Sarscoronavirus-2 Serology Assays in Serum and Dried Blood Spot Matrices	8
Approaches to Overcome the Challenge of Sample Stability for Flow Cytometry Analysis in Clinical Trials	8
Criteria of Slope and Endogenous Level for Selection of Matrix in the Quantitation of Endogenous Compounds by LC-MS/MS	8
Recommendations for the Content and Management of Certificates of Analysis for Reference Standards from the GCC for Bioanalysis	8
Dried Matrix Spots in Forensic Toxicology	8
Stability of Nafamostat in Intravenous Infusion Solutions, Human Whole Blood and Extracted Plasma: Implications for Clinical Effectiveness Studies	8
Label-Free Immunosensing of Telomerase Using Bio-Conjugation of Biotinylated Antibody to Poly(Chitosan) Gold Nanoparticles	8
Towards a More Patient-Centric Assessment of Immunogenicity for Low-Risk Biologics in Immuno-Oncology Clinical Trials	7
Solutions for Hematocrit Bias in Dried Blood Spot Hormone Analysis	7
The importance of Quality Critical Reagents for the Entire Developmental Lifecycle of a Biopharmaceutical: A Pharmacokinetic Case Study	7
A Brave New World?	7
Advancements in Practical and Scientific Bioanalytical Approaches to Metabolism Studies in Drug Development	7
A Biomarker Assay Validation Approach Tailored to The Context of Use and Bioanalytical Platform	7
Bioanalytical Challenges and Strategies of Crispr Genome Editors	7
LC–MS/MS Assay of Fluoropezil and Its Two Major Metabolites in Human Plasma: An Application to Pharmacokinetic Studies	7
Critical Reagents: Evolution of WRIB Recommendations on Critical Reagents	7
Development of a selective, sensitive and robust oxyntomodulin dual monoclonal antibody immunoassay	7
A Bridging Immunogenicity Assay for Anti-Cabiralizumab Antibodies: Overcoming the Low Assay Cut Point and Drug Tolerance Challenges	7
Fabry Disease Biomarkers in Patients Switched From Enzyme-Replacement Therapy to Migalastat Oral Chaperone Therapy	6
Technique Development of High-Throughput and High-Sensitivity Sample Preparation and Separation for Proteomics	6
Comparing Singlet and Duplicate Immunogenicity Assay in Human Plasma for Pembrolizumab Using Gyrolab®	6
Biomarker Context-Of-Use: How Organizational Design Can Impact the Implementation of the Appropriate Biomarker Assay Strategy	6
A Simple Isotope-Labeled UHPLC–MS/MS Assay for Simultaneous Quantification of Methotrexate, Imatinib and Dasatinib	6
Chromatographic analysis of ciprofloxacin and metronidazole in real human plasma: green analytical chemistry perspective	6
Solid-Phase Microextraction for Assessment of Plasma Protein Binding, a Complement to Rapid Equilibrium Dialysis	6
Analytical Techniques for Monitoring of Toluene and Xylene Exposure Biomarkers Hippuric Acid and Methylhippuric Acid in Human Urine Samples	6
Green Bioanalysis: An Innovative and Eco-Friendly Approach for Analyzing Drugs in Biological Matrices	6
Analysis of Tigecycline in the Cerebrospinal Fluid and Serum of Patients with Acinetobacter Baumannii Central Nervous System Infection	6
Degradation of Vancomycin in External Quality Assessment Samples is a Factor to Underestimate Its Concentration	6
Bioanalysis by LC-MS/MS and Preclinical Pharmacokinetic Interaction Study of Ribociclib and Oleanolic Acid	6
Validation of an HPLC Method for Estimation of Cefotaxime from Dried Blood Spot: Alternative to Plasma-Based PK Evaluation in Neonates	6
Integrity and Efficiency: AbbVie’s Journey of Building an Integrated Nonregulated Bioanalytical Laboratory	5
Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective	5
Novel microchip electrophoresis–contactless conductivity method for detection and characterization of extracellular vesicles enriched for exosomes and microvesicles	5
Development of LC–MS/MS Method for Cyanoenone Triterpenoid Determination to Support CNS Tissue Distribution Study	5
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (	5

Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline	5
Using Mitra Sampling to Support First-in-Human Pharmacokinetic Evaluations for PF-07059013	5
Unique challenges required reassessment and alterations to critical reagents to rescue a neutralizing antibody assay	5
Microflow LC–MS/MS to improve sensitivity for antisense oligonucleotides bioanalysis: critical role of sample cleanness	5
LC–MS/MS method for quantification of raspberry ketone in rat plasma: application to preclinical pharmacokinetic studies	5
Uncovering the Green Frontier: Harnessing Deep Eutectic Solvents for Sustainable Bioanalysis	5
Validation of low-volume sampling devices for pharmacokinetic analysis: technical and logistical challenges and solutions	5
The case for bioanalytical analyzer	5
Liquid chromatographic methods in the determination of inosine monophosphate dehydrogenase enzyme activity: a review	5
2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolonga	5
Quantification of a promising JNK inhibitor and nitrovasodilator IQ-1 and its major metabolite in rat plasma by LC–MS/MS	5
Simple Method to Determine the Concentration and Incorporation Ratio of Ruthenium-Labeled Antibodies	4
Simultaneous estimation of rutin and donepezil through RP-HPLC: implication in pharmaceutical and biological samples	4
Determination of Favipiravir in Human Plasma using Homogeneous Liquid–Liquid Microextraction followed by HPLC/UV	4
Development and validation of an LC–MS/MS method for D- and L-2-hydroxyglutaric acid measurement in cerebrospinal fluid, urine and plasma: application to glioma	4
The advantages of working with a central laboratory for conducting clinical trials	4
A Survey of Pharmacokinetic Bioanalytical Methods in Biosimilar Biological License Applications for the Assessment of Target and Antidrug Antibody Effects	4
Novel Sorptive Microextraction Approaches in Bioanalysis: The Paradigm of Endocrine Disruptors	4
Feedback from the 8th European Bioanalysis Forum Young Scientist Symposium	4
A platform immunoassay for the quantification of biotherapeutics with glycine-serine linkers	4
Challenges and Current Advances in the Methodology of Thyroglobulin Measurements	4
A Low-Voltage Electro-Membrane Extraction for Quantification of Imatinib and Sunitinib in Biological Fluids	4
An LC-MS/MS method for the determination of Lifitegrast in human plasma and tear and its application in the pharmacokinetic study	4
LC-MS/MS-based bioanalysis of branched-chain and aromatic amino acids in human serum	4
Peripheral blood mononuclear cells isolation from mouse and rabbit blood to quantify active nucleotide and define brincidofovir dose for smallpox	4
Quantification of Oxalate by Novel LC–MS/MS: Assay Development, Validation and Application in Lumasiran Clinical Trials	4
A Smartphone Digital Image Colorimetric Method Based on Nanoparticles for Determination of Lamotrigine	4
Assessment of alteration in antiviral plasma concentration across dialysis days: computational and analytical study	4
Validation and Comprehensive Analysis of Streptococcus pneumoniae IgG WHO Enzyme-Linked Immunosorbent Assay in an Indian Reference Laboratory	4
Comparison of Pharmacokinetic Study Profiles of Insulin in Rat Plasma Through Conventional Sampling and Microsampling by Micro-LC–MS/MS	4
Novel Hydrophilic-Phase Extraction, HILIC and High-Resolution MS Quantification of an RNA Oligonucleotide in Plasma	4
Single-Day Protein LC–MS Bioanalysis: Can Next-Generation Trypsins Cut It?	4
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectra	4
Role of miRNA-21 in cancer and its application in electrochemical bioanalysis	4
Signal-to-noise Ratio to Assess Magnitude, Kinetics and Impact on Pharmacokinetics of the Immune Response to an Adalimumab Biosimilar	4
Pitfalls in bioanalytical work with a Japanese CRO or sponsor: from a project risk management perspective	4
Simultaneous Determination of Four Antibiotics in Human Plasma by High-Performance LC–MS/MS: Application to Therapeutic Drug Monitoring	4
ELISA array-based immunoassay for multiplex detection of osteoporosis-relevant biomarkers	4
Bioanalysis of tucatinib and metabolite, and a five-way cross-validation to support clinical pharmacokinetic analysis	3
Lacidipine: Review of Analytical Methods Developed for Pharmaceutical Dosage forms and Biological Fluids	3
Deploying a Rapid Point-Of-Care Polymerase Chain Reaction Test for Sars-Cov-2 in a Clinical Research Unit to Ensure Healthy Volunteer Safety	3
The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays	3
Determination and Validation of Aprepitant in Rat Plasma using LC−MS/MS	3
Hollow Fiber-in-Syringe Equilibrium Sampling Through Supported-Liquid Membrane for Evaluation of Drug-Plasma Binding	3
Stability of Nonsteroidal Anti-Inflammatory Drugs in Urine and Solution: Effects of Degradation on Analytical Assessment	3
Quantitation of Vistusertib by UHPLC-MS/MS in Rat Plasma and its Application to a Pharmacokinetic Study	3
Measurement of Free Fraction, Total Concentration and Protein Binding for Testosterone, Triiodothyronine and Thyroxine	3
Sensitive LC-MS/MS Quantification of Unconjugated Maytansinoid DM4 and its Metabolite S-methyl-DM4 in Human Plasma	3
A New Method for the Therapeutic Drug Monitoring of Chlorpromazine in Plasma by Gas Chromatography–Mass Spectrometry Using Dispersive Liquid–Liquid Microextraction	3
Development of an Immunoassay for Aglycosylated Murine IgG1 in Mouse Serum via Generation of a Specific Tool Antibody	3
Inclusion of dilution quality control samples in quantitative LC-MS bioanalysis	3
Conduct of Remote Inspections: Challenges and Progress	3
Advancing the Use of Molecularly Imprinted Polymers in Bioanalysis: The Selective Extraction of Cotinine in Human Urine	3
Development and application of a multi-sugar assay to assess intestinal permeability	3
A Singlicate Immunogenicity Method to Detect Anti-Polyethylene Glycol Antibodies: Pre- and Post-Dose of PEGylated Therapies	3
Quantitative Chromatographic Method Development for Residual Lidocaine in Topical Systems and Biological Samples	3
Critical Reagents in Flow Cytometry, Instrumentation and Application in Drug Discovery Development	3
Solid-Phase Extraction of Gallic Acid and Ascorbic Acid in Fruits Using Polymerized Deep Eutectic Solvent-Modified Substrate	3
Less is More: An Ecological and Economic Point of View on Appropriate Use of Lab Testing for Covid-19 Patients	3
Expanding Assay Range to Accommodate a Monoclonal Antibody Therapeutic Quantification in Blood and Cerebrospinal Fluid	3
A New Approach with Dried Plasma Spots: A Rapid Determination of Antidepressants and Antipsychotics by Fast GC–MS	3
A Cell-Based FcRn-dependent Recycling assay for Predictive Pharmacokinetic assessment of Therapeutic Antibodies	3
Application of Middle-Down Approach in Quantitation and Catabolite Identification of Protein by LC–high-Resolution Mass Spectrometry	3
Iron oxide nanozymes as versatile analytical tools: an overview of their application as detection technique	3
A Robust Enzyme-Linked Immunosorbent Assay to Measure Serum Ramucirumab Concentrations	3
A comprehensive LC–MS based study of factors influencing biotinylation of critical reagents	3
Green Sample Preparation in Bioanalysis: Where Are We Now?	3
Development and Validation of LC–MS/MS Method for Quantitation of Sodium Oligomannate in Human Plasma, Urine and Feces	3
Progress Towards Global Standardization for Quantitative Flow Cytometry	3
Flow cytometry vs conventional methods for the evaluation of anti-PF4/heparin antibodies: a single center study	3
Recent advances in gold nanoparticle-based colorimetric aptasensors for chemical and biological analyses	3
Development of a Novel Elisa to Detect Total Factor D in the Presence of High Levels of Pegylated Anti-Factor D Fab	3