OOIR: Observatory of International Research

Papers

(The TQCC of AAPS Journal is 6. 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 2021-05-01 to 2025-05-01.)

Article	Citations
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network	328
Deciphering the Dynamic Complexities of the Liver Microenvironment — Toward a Better Understanding of Immune-Mediated liver Injury Caused by Immune Checkpoint Inhibitors (ILICI)	149
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022	105
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate	80
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease	63
A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models	59
A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions	55
Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy	45
Therapeutic Genome Editing and In Vivo Delivery	41
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy	40
A Novel Approach for Quantifying the Pharmacological Activity of T-Cell Engagers Utilizing In Vitro Time Course Experiments and Streamlined Data Analysis	37
Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab	35
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation	34
The Drug Titration Paradox in the Presence of Intra-Individual Variation: Can we Estimate the True Concentration-Effect Relationship?	32
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal	29
Machine Learning and Artificial Intelligence in Pharmaceutical Research and Development: a Review	26
Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics	26
A Pharmacometrics Model to Characterize a New Type of Target-Mediated Drug Disposition (TMDD) – Nonlinear Pharmacokinetics of Small-Molecule PF-07059013 Mediated By Its High-capacity Pharmacological T	24
Gastrointestinal Bile Salt Concentrations in Healthy Adults Under Fasted and Fed Conditions: A Systematic Review and Meta-Analysis for Mechanistic Physiologically-Based Pharmacokinetic (PBPK) Modellin	24
Non-viral Vectors in Gene Therapy: Recent Development, Challenges, and Prospects	24
Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine	24
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method	23
Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development	23
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent	22
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices	22

Exosomes in Atherosclerosis, a Double-Edged Sword: Their Role in Disease Pathogenesis and Their Potential as Novel Therapeutics	20
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines	20
Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker	20
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data	19
Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates	19
PBPK Simulation-Based Evaluation of Ganciclovir Crystalluria Risk Factors: Effect of Renal Impairment, Old Age, and Low Fluid Intake	19
Understanding Drug Delivery to the Brain Using Liposome-Based Strategies: Studies that Provide Mechanistic Insights Are Essential	19
Nomlabofusp, a Fusion Protein of Human Frataxin and a Cell Penetrant Peptide, Delivers Mature and Functional Frataxin into Mitochondria	19
Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs	18
Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories	18
Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies	18
Simultaneous Estimation of fm and FG Values Directly from Clinical Drug-Drug Interaction Study Data	17
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models	17
Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of Iberdomide	17
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions	16
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat	16
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework	16
Novel Selective Quantification of Zinpentraxin Alfa Biotherapeutic in the Presence of Endogenous Isomer in Plasma Samples of Idiopathic Pulmonary Fibrosis Patients Using Immunoaffinity LC–MS	16
Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology Industries	16
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products	16
Determining the Degree of Sulfo-tag Conjugation to AAV5 Vectors by LC-HRMS and Evaluating the Effects on Antibody Binding Affinity and Bridging Assay Sensitivity	15
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome	15
Drug Dissolution in Oral Drug Absorption: Workshop Report	15
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes	15
Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper	15
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans	15
Lipid Nanoparticles for mRNA Delivery in Cancer Immunotherapy	15
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing	15
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	15
Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions	14
Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures	14
Flux-Based Formulation Development—A Proof of Concept Study	14
A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic	14
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling	13
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	13
ICH M10 Bioanalytical Method Validation Guideline-1 year Later	13
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	13
Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence	12
A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume	12
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study	12
There is Only One Valid Definition of Clearance: Critical Examination of Clearance Concepts Reveals the Potential for Errors in Clinical Drug Dosing Decisions	11
Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody	11
Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver	11
Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology	11
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay	11
Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References	11
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submi	11
Correction: Preclinical In Vivo Data Integrated in a Modeling Network Informs a Refined Clinical Strategy for a CD3 T‑Cell Bispecific in Combination with Anti‑PD‑L1	11
Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters	10
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route	10

Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	10
The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models	10
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA	10
In Vitro Assessment of Transporter Mediated Perpetrator DDIs for Several Hepatitis C Virus Direct-Acting Antiviral Drugs and Prediction of DDIs with Statins Using Static Models	10
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents	10
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”	9
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications	9
Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method	9
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety	9
Quantitative Systems Pharmacology Modeling of Avadomide-Induced Neutropenia Enables Virtual Clinical Dose and Schedule Finding Studies	9
RNA Nanomedicine: Delivery Strategies and Applications	9
Leveraging Buprenorphine and Halofantrine as Tool Molecules to Develop a Novel Semi-Physiologically based Pharmacokinetic Model Accounting for Gastro-Intestinal Lymphatic Absorption and Enabling Cross	9
From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation	9
Sinusoidal Organic Anion-Transporting Polypeptide 1B1/1B3 and Bile Canalicular Multidrug Resistance-Associated Protein 2 Play an Essential Role in the Hepatobiliary Disposition of a Synthetic Cyclic D	9
Navigating Through Cell-Based In vitro Models Available for Prediction of Intestinal Permeability and Metabolism: Are We Ready for 3D?	9
A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities	9
Zwitterionic Polymer Coatings Enhance Gold Nanoparticle Stability and Uptake in Various Biological Environments	9
Performance Evaluation of Montelukast Pediatric Formulations: Part II — a PBPK Modelling Approach	9
Is It Time to Use Modeling of Cellular Transporter Homeostasis to Inform Drug-Drug Interaction Studies: Theoretical Considerations	9
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	8
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability	8
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	8
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays	8
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models	8
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials	8
Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models	8
Does an Intradermal Vaccination for Monkeypox Make Sense?	7
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation	7
Model-Informed Immunogenicity Assessment of Nivolumab as Monotherapy and in Combination with Ipilimumab	7
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder	7
Correction: Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis–Hastings Algorithm	7
Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary	7
Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning	7
Structure-Based SAR in the Design of Selective or Bifunctional Nociceptin (NOP) Receptor Agonists	7
Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies	7
Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters	7
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors	7
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?	7
DNA Methylome and Transcriptome Study of Triterpenoid CDDO in TPA-Mediated Skin Carcinogenesis Model	7
Lessons from CDER’s Quality Management Maturity Pilot Programs	7
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS	7
Modulating Oral Delivery and Gastrointestinal Kinetics of Recombinant Proteins via Engineered Fungi	7
Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study	7
Unraveling Ceftriaxone Dosing: Free Drug Prediction, Threshold Optimization, and Model Validation	6
Considerations in Kp,uu,brain-based Strategy for Selecting CNS-targeted Drug Candidates with Sufficient Target Coverage and Substantial Pharmacodynamic Effect	6
Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial	6
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2	6
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point	6
Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies	6
An Integrated Analysis of Dostarlimab Immunogenicity	6
Determination of the Number of Tissue Groups of Kinetically Distinct Transit Time in Whole-Body Physiologically Based Pharmacokinetic (PBPK) Models II: Practical Application of Tissue Lumping Theories	6
Direct Comparison of the Prediction of the Unbound Brain-to-Plasma Partitioning Utilizing Machine Learning Approach and Mechanistic Neuropharmacokinetic Model	6
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium	6
IFN-γ/IL-2 Double-Color FluoroSpot Assay for Monitoring Human Primary T Cell Activation: Validation, Inter-Laboratory Comparison, and Recommendations for Clinical Studies	6
Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants	6
Optimization of Peripheral Blood Mononuclear Cell Processing for Improved Clinical ELISpot Assay Performance	6
Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models	6
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products	6
Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	6
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development	6
A Two-Pore Physiologically Based Pharmacokinetic Model to Predict Subcutaneously Administered Different-Size Antibody/Antibody Fragments	6