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 2020-11-01 to 2024-11-01.)

Article	Citations
Flow Cytometry: Principles, Applications and Recent Advances	65
Validation of Dried Blood Spot Sample Modifications to Two Commercially Available Covid-19 Igg Antibody Immunoassays	50
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	37
Dried Blood Spots in Doping Analysis	27
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( Part 1 –R	26
Detection of Sars-Cov-2At the Point of Care	26
Determination of Favipiravir in Human Plasma using Homogeneous Liquid–Liquid Microextraction followed by HPLC/UV	25
Green Bioanalytical Sample Preparation: Fabric Phase Sorptive Extraction	24
Cytochrome P450 Enzymes: A Review on Drug Metabolizing Enzyme Inhibition Studies in Drug Discovery and Development	23
Assessment of Low Volume Sampling Technologies: Utility in Nonclinical and Clinical Studies	22
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A –Recomm	21
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 &	21
Rapid Development of Analytical Methods for Evaluating Pandemic Vaccines: A Covid-19 Perspective	20
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	18
How the Covid-19 Pandemic is Changing Clinical Trial Conduct and Driving Innovation in Bioanalysis	17
Validation and Application of Hybridization Liquid Chromatography-Tandem Mass Spectrometry Methods for Quantitative Bioanalysis of Antisense Oligonucleotides	17
Electromembrane Extraction of Peptides and Amino Acids–Status and Perspectives	15
Development of a Lc–Ms/Ms Method for the Quantification of Toxic Payload Dm1 Cleaved from Bt1718 in a Phase I Study	15
Recommendations on qPCR/ddPCR Assay Validation by GCC	15
With Great Power Comes Great Responsibility: High-Dimensional Spectral Flow Cytometry to Support Clinical Trials	14
A Flow Cytometric Journey Into Cell Cycle Analysis	14
Determination of Levofloxacin by HPLC with Fluorescence Detection in Human Breast Milk	14
Validation of Enantioseparation and Quantitation of an Active Metabolite of Abrocitinib in Human Plasma	14
Assessing the Impact of Nonspecific Binding on Oligonucleotide Bioanalysis	14
The role of Ligand-Binding Assay and LC–MS in the Bioanalysis of Complex Protein and Oligonucleotide Therapeutics	13

Glycoproteomic Bioanalysis of Exosomes by LC–MS for Early Diagnosis of Pancreatic Cancer	13
Novel Hydrophilic-Phase Extraction, HILIC and High-Resolution MS Quantification of an RNA Oligonucleotide in Plasma	13
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (	13
A Low-Voltage Electro-Membrane Extraction for Quantification of Imatinib and Sunitinib in Biological Fluids	13
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	12
Volumetric Absorptive Microsampling: Its Use in Covid-19 Research and Testing	11
A Minireview on Nanoparticle-Based Sensors for the Detection of Coronaviruses	11
LC–MS/MS Bioanalytical Method for Quantification of Binimetinib and Venetoclax, and their Pharmacokinetic Interaction	11
Microflow LC–MS/MS to improve sensitivity for antisense oligonucleotides bioanalysis: critical role of sample cleanness	11
Application of Microextraction Techniques in Alternative Biological Matrices with Focus on Forensic Toxicology: A Review	10
A Strategic Approach to Nonclinical Immunogenicity Assessment: A Recommendation from the European Bioanalysis Forum	10
In Vitro Testing of the HemaPEN Microsampling Device for the Quantification of Acetaminophen in Human Blood	10
Analytical Method Validation for Biomarkers As a Drug Development Tool: Points to Consider	10
Development of a Bioanalytical Method for an Antisense Therapeutic Using High-Resolution Mass Spectrometry	9
Validation of an LC–MS/MS method for the determination of sotorasib, a KRAS ^G12C inhibitor, in human plasma	9
Quantification of Infliximab and Adalimumab in Human Plasma by a Liquid Chromatography Tandem Mass Spectrometry Kit and Comparison with Two ELISA Methods	9
Biopharmaceutical Quality Control with Mass Spectrometry	9
Bioanalytical method validation and sample analysis for nirmatrelvir in dried blood collected using the Tasso-M20 device	9
Validation of High-Throughput, Semiquantitative Solid-Phase Sarscoronavirus-2 Serology Assays in Serum and Dried Blood Spot Matrices	8
Applying Contextofuse to Quantitative Polymerase Chain Reaction Method Validation and Analysis: A Recommendation From the European Bioanalysis Forum	8
pH-induced Homogeneous liquid–liquid Microextraction Method based on new Switchable Deep Eutectic Solvent for the Extraction of Three Antiepileptic Drugs from Breast Milk	8
Quantitation of Ivosidenib in Human Plasma Via LC–MS/MS and its Application in Clinical Trials	8
Pharmacokinetic Drug–Drug Interactions: An Insight into Recent Us Fda-Approved Drugs for Prostate Cancer	8
Regen-Cov ^® Antibody Cocktail Bioanalytical Strategy: Comparison of Lc-Mrm-Ms and Immunoassay Methods for Drug Quantification	8
2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (	8
Adaptation of Elecsys ^® Anti-Severe Acute Respiratory Syndrome Coronavirus-2 Immunoassay to Dried Blood Spots: Proof Of Concept	8
Quantification of Abemaciclib and Metabolites: Evolution of Bioanalytical Methods Supporting a Novel Oncolytic Agent	8
HPLC Method for Simultaneous Estimation of Paclitaxel and Baicalein: Pharmaceutical and Pharmacokinetic Applications	7
Rapid Diagnostics for Sars-Cov-2 Virus: Point-Of-Care Testing and Lessons Learned During the Pandemic	7
Monitoring of Hemoglobin and Erythropoiesis-Related mRNA with Dried Blood Spots in Athletes and Patients	7
Sample Preparation in Capillary Electrophoresis for the Determination of Small Molecule Drugs and Metabolites in Urine	7
Ocular Bioanalysis of Moxifloxacin and Ketorolac Tromethamine in Rabbit Lacrimal Matrix Using Liquid Chromatography–Tandem Mass Spectrometry	7
Review on In Vivo Profiling of Drug Metabolites with Lc-Ms/Ms in the Past Decade	7
A Novel Hydrophilic Interaction Chromatography Assay Characterization of 4-Pyridoxic Acid, an Emergent Renal Organic Anion Transporter 1/3 Transporter Biomarker	7
Recent Advances in Chiral Analysis for Biosamples in Clinical Research and Forensic Toxicology	7
High-sensitivity Quantification of Antisense Oligonucleotides for Pharmacokinetic Characterization	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
Recommendations on ELISpot Assay Validation by the GCC	6
Understanding quantitative polymerase chain reaction bioanalysis issues before validation planning: Japan Bioanalysis Forum discussion group	6
Characterization of Robust Immune Responses to a Bispecific Antibody, a Novel Class of Antibody Therapeutics	6
Biomarker Context-Of-Use: How Organizational Design Can Impact the Implementation of the Appropriate Biomarker Assay Strategy	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
Quantification of antibody–drug conjugate PYX-201 in rat and monkey plasma via ELISA and its application in preclinical studies	6
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	6
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	6
Solutions for Hematocrit Bias in Dried Blood Spot Hormone Analysis	6
Analytical Considerations for Reducing the Matrix Effect for the Sphingolipidome Quantification in Whole Blood	6
Analytical Comparison of ELISA and Mass Spectrometry for Quantification of Serum Hepcidin in Critically Ill Patients	6
Bioanalysis and the Oncology Revolution	6

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	6
Criteria of Slope and Endogenous Level for Selection of Matrix in the Quantitation of Endogenous Compounds by LC-MS/MS	5
LC–MS/MS Assays to Quantify Sulfatides and Lysosulfatide in Cerebrospinal Fluid of Metachromatic Leukodystrophy Patients	5
Flow Cytometry and Pharmacokinetics	5
Introducing Dendritic Cell Antibody Internalization as an Immunogenicity Risk Assessment Tool	5
Preclinical Pharmacokinetics of 4-Hydroxy Isoleucine Using Lc–Ms/Ms: A Potential Polycystic Ovary Syndrome Phytopharmaceutical Therapeutics	5
Progress Towards Global Standardization for Quantitative Flow Cytometry	5
Quantification of a promising JNK inhibitor and nitrovasodilator IQ-1 and its major metabolite in rat plasma by LC–MS/MS	5
Simultaneous Quantification of Dexamethasone and 6β-hydroxydexamethasone in Rabbit Plasma, Aqueous and Vitreous Humor, and Retina by UHPLC–MS/MS	5
Lessons Learned from the COVID-19 Pandemic and its Impact on Bioanalysis and Drug Development	5
Critical Reagent Characterization and Re-Evaluation to Ensure Long-Term Stability: Two Case Studies	5
Uncovering the Green Frontier: Harnessing Deep Eutectic Solvents for Sustainable Bioanalysis	5
Comparing Singlet and Duplicate Immunogenicity Assay in Human Plasma for Pembrolizumab Using Gyrolab®	5
Microsampling in Pediatric Studies: Pharmacokinetic Sampling For Baricitinib (Olumiant™) in Global Pediatric Studies	5
Critical Reagent Generation, Characterization, Handling and Storage Workflows: Impact on Ligand Binding Assays	5
Using Multiple Platforms for Critical Reagents Selection Process to Support Pharmacokinetic Ligand-Binding Assay Development	5
A Cell-Based FcRn-dependent Recycling assay for Predictive Pharmacokinetic assessment of Therapeutic Antibodies	5
Integrity and Efficiency: AbbVie’s Journey of Building an Integrated Nonregulated Bioanalytical Laboratory	5
In Vitro Immunogenicity Prediction: Bridging between Innate and Adaptive Immunity	4
Statistical Methods of Screening Cut Point Determination in Immunogenicity Studies	4
Direct bioanalysis or indirect calculation of target engagement and free drug exposure: do we apply double standards?	4
Nitrosamine Impurities: from Raw Materials to Final Drug Product	4
A Review of Bioanalytical Applications of Microextraction Techniques Combined with Derivatization	4
High-Sensitivity Workflow for LC–MS-Based Analysis of GALNAC-Conjugated Oligonucleotides: A Case Study	4
Key Points of Technical Review for the Registration of Sars-Cov-2 Antigen/Antibody Tests	4
Solid-Phase Microextraction for Assessment of Plasma Protein Binding, a Complement to Rapid Equilibrium Dialysis	4
Recommendations for the Content and Management of Certificates of Analysis for Reference Standards from the GCC for Bioanalysis	4
Evaluation of hemaPEN ^® sampling device for measurement of cocaine and metabolites in capillary blood by LC-MS/MS	4
The Impact of Ligand Binding Based Assays Critical Reagent Characterization and Storage	4
Assay Concept for Detecting Anti-Drug IgM in Human Serum Samples by using a Novel Recombinant Human IgM Positive Control	4
Non-Regulated LC–MS/MS Bioanalysis in Support of Early Drug Development: A Novartis Perspective	4
Chromatographic Estimation of a Novel Triple-Therapy Combination Targeting Helicobacter Pylori Eradication in Different Matrices	4
Method Development Workflow for Quantifying Protein Biomarkers by Hybrid LC–MS/MS	4
Challenges with Development of a Pharmacokinetics Assay to Measure a Variably Glycosylated Fusion Protein	4
Simple Method to Determine the Concentration and Incorporation Ratio of Ruthenium-Labeled Antibodies	4
The importance of Quality Critical Reagents for the Entire Developmental Lifecycle of a Biopharmaceutical: A Pharmacokinetic Case Study	4
Innovation in Bioanalytical Strategies and in vitro Drug–drug Interaction Study Approaches in Drug Discovery	4
Recommendations and Discussion Points on Immunogenicity, Biomarkers, Automation/Technology and Protein–MS From the 2021 European Bioanalysis Forum Focus Workshops	4
COVID-19’s Impact on Bioanalytical Labs	4
HPLC–MS/MS Studies of Brimonidine in Rabbit Aqueous Humor By Microdialysis	4
Bioanalytical Strategy for the Characterization and Bioanalysis of Biologics: A Global, Nonregulated Bioanalytical Lab Perspective	4
Bioanalysis of tucatinib and metabolite, and a five-way cross-validation to support clinical pharmacokinetic analysis	4
A Survey of Pharmacokinetic Bioanalytical Methods in Biosimilar Biological License Applications for the Assessment of Target and Antidrug Antibody Effects	4
Green Bioanalysis: An Innovative and Eco-Friendly Approach for Analyzing Drugs in Biological Matrices	4
Advancements in Practical and Scientific Bioanalytical Approaches to Metabolism Studies in Drug Development	4
Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective	3
Chromatographic analysis of ciprofloxacin and metronidazole in real human plasma: green analytical chemistry perspective	3
Greener Bioanalytical Sample Preparation. What is Next?	3
Quantification of Oxalate by Novel LC–MS/MS: Assay Development, Validation and Application in Lumasiran Clinical Trials	3
Dispersive Liquid–Liquid Microextraction of 11-nor-Δ9-tetrahydrocannabinol-carboxylic Acid applied to Urine Testing	3
Validation of a Dried Blood Spot Method to Measure Tacrolimus Concentrations in Small Volumes of Mouse Blood	3
Determination of caffeine, paraxanthine, theophylline and theobromine in premature infants by HILIC-MS/MS	3
Determination of drug-to-antibody ratio of antibody–drug conjugate in biological samples using microflow-liquid chromatography/high-resolution mass spectrometry	3
A Multilaboratory Validation Study of Lc/Ms Biomarker Assays for Three Lysophosphatidylcholines	3
Novel Sequential Immunocapture Microflow LC/MS/MS Approach to Measuring PTH-Fc Protein in Human Serum	3
Efficiency of Pooled Surveillance Testing in Academic Labs to Detect and Inhibit Covid-19 Outbreaks	3
The Potential of Oral Fluid in 1Drug Monitoring: An Update	3
Validation of an HPLC Method for Estimation of Cefotaxime from Dried Blood Spot: Alternative to Plasma-Based PK Evaluation in Neonates	3
LC–MS/MS Method for Simultaneous Estimation of Raloxifene, Cladrin in rat Plasma: Application in Pharmacokinetic Studies	3
Outcomes of Adverse Analytical Findings in Individual and Team Sports	3
Critical Reagents for Ligand-Binding Assays: Process Development Methodologies to Enable High-Quality Reagents	3
A Sensitive, Robust and High-Throughput Isotope Dilution LC–MS/MS Method for Quantifying Three Folate Forms in Serum	3
Increasing Robustness, Reliability and Storage Stability of Critical Reagents by Freeze-Drying	3
Simultaneous Estimation of Raloxifene and Cladrin by HPLC: Application to Metabolic Stability Studies in Different Species	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
Evaluating the Use of Locked Nucleic Acid Capture Probes in Hybrid LC–MS/MS Analysis of siRNA Analytes	3
Cloud Solutions for GxP Laboratories: Considerations for Data Storage	3
Signal-to-noise Ratio to Assess Magnitude, Kinetics and Impact on Pharmacokinetics of the Immune Response to an Adalimumab Biosimilar	3
Analytical Techniques for Monitoring of Toluene and Xylene Exposure Biomarkers Hippuric Acid and Methylhippuric Acid in Human Urine Samples	3
Critical Reagents Issues & Solutions for Anti-Drug Antibody Assays	3
Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum	3
Comparison of Liquid–Liquid Extraction, Microextraction and Ultrafiltration for Measuring Free Concentrations of Testosterone and Phenytoin	3
Current and Effective Strategies for Critical Reagent Characterization, Storage, Stability, Retesting and Life Cycle Management for Ligand-Binding Assays and Flow Cytometry	3
Chemical Derivatization in Combination with Supercritical Fluid Chromatography to Improve Resolution of Stereoisomers	3
A Validated Capillary Microsampling Liquid Chromatography–Tandem Mass Spectrometry Method for Quantification of Antisense Oligonucleotides in Mouse Serum	3
Method development for the quantification of lead levels in whole blood sampled on Mitra ^® with VAMS ^® tips by inductively coupled	3
Whole Blood Stability Evaluation of Monoclonal Antibody Therapeutics Using Volumetric Absorptive Microsampling	3
Recent advances in gold nanoparticle-based colorimetric aptasensors for chemical and biological analyses	3
A Smartphone Digital Image Colorimetric Method Based on Nanoparticles for Determination of Lamotrigine	3