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 2022-05-01 to 2026-05-01.)

Article	Citations
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022	76
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy	50
A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models	42
Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics	41
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal	40
Matching in Organ Impairment Studies: A Systematic Review of Accepted Methodologies	39
A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions	37
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation	33
Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy	29
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network	29
Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab	28
Application of a Modified In Situ Perfusion Model to Quantify Intestinal Drug Excretion and Transporter-Mediated Interactions after Intravenous Administration	28
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate	27
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease	27
The Drug Titration Paradox in the Presence of Intra-Individual Variation: Can we Estimate the True Concentration-Effect Relationship?	26
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method	25
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	25
Pharmacokinetics of Inhibitors of Succinyl-CoA:3-Ketoacid CoA Transferase in Sprague–Dawley Rats, and the Effect of a High-Fat Diet	25
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices	25
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent	24
Best Practices for Performing Analytical and Functional Biosimilarity Assessment of Recombinant Monoclonal Antibody Biosimilars	24
Industry Practices in Oligonucleotide Tissue Biodistribution Assessment: An IQ consortium Cross-Industry Survey of Current Approaches and Emerging Trends	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
Perspectives on PCR-Based Cellular Kinetics and Biodistribution Analysis for Emerging Adoptive Cell Therapies	24
Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance	23

Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine	23
A Bottom-up Approach for Mutant and Wild Type Collies Using Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using Loperamide	22
Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability	21
Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs	20
Simultaneous Estimation of fm and FG Values Directly from Clinical Drug-Drug Interaction Study Data	20
A Quantitative Approach to Guiding Target Antigen Selection and Antibody Optimization in Recycling Antibody Discovery	20
Investigation of 2,4 Di-tert-butylphenol Leaching from Multidose Ophthalmic Devices into Tacrolimus Micellar Formulations	20
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines	19
Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies	18
Quantitative Investigation of ATP Switch Concept of STA551 Through Combined In Vivo Tissue Distribution Studies and Physiologically Based Pharmacokinetic Modeling	18
Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of Iberdomide	18
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data	18
Nomlabofusp, a Fusion Protein of Human Frataxin and a Cell Penetrant Peptide, Delivers Mature and Functional Frataxin into Mitochondria	17
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions	17
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	17
Theoretical and Numerical Investigation of the Consistency of Model Comparisons in Pharmacometrics	16
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	16
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans	16
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework	16
Lipid Nanoparticles for mRNA Delivery in Cancer Immunotherapy	16
Drug Dissolution in Oral Drug Absorption: Workshop Report	15
New Frontiers in ADC Analysis: Advances in Chromatography, Electrophoresis, and Mass Spectrometry	15
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products	15
Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation	15
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes	14
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	14
Target Abundance in Pharmacological Target-Mediated Drug Disposition (TMDD) for Small Molecules — A Proteomics Approach	14
Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper	13
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing	13
Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions	13
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome	13
Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures	13
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling	13
Regulatory Divergence in Narrow Therapeutic Index Drugs: A Comparative Review of the US, EU, Japan, Canada, and South Korea	13
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	12
Insights from a Survey of Drug Formulation Experts: Challenges and Preferences in High-Concentration Subcutaneous Biologic Drug Development	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
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	12
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study	11
Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver	11
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay	11
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	11
A Design of Experiments and Risk Management-Driven Analytical Platform for Charge Variant Analysis of Therapeutic Antibodies by Imaged Capillary Isoelectric Focusing	11
Innovative In Vitro-In Silico Platform for Dose–Response Modeling in Canine Bladder Cancer: A 3D Organoid- and Mathematics-Based Approach	11
ICH M10 Bioanalytical Method Validation Guideline-1 year Later	11
Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology	11
Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules	10
Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling	10
Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody	10
Effect of Incentivizing Pediatric Studies on the Development of Pediatric-Friendly Formulations	10

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	10
The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models	10
Simultaneous Target-Mediated Drug Disposition-Pharmacodynamic (TMDD-PD) Modeling of Finasteride and Dutasteride: Impact of Target Binding and Turnover on Non-linear Pharmacokinetics	10
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”	9
Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	9
Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP	9
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submi	9
Nitrosamines Risk Assessment for Biopharmaceutics Classification System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokin	9
Biodistribution of Cerivastatin, Repaglinide, Glyburide, Rosuvastatin, and Valsartan in Cynomolgus Monkeys and PBPK Analysis	9
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA	9
Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site	8
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents	8
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route	8
Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review	8
PBPK Modelling of PROTACs: Learnings from ARV-110 as a Case Example	8
Spatiotemporal Profiling of Intratumoral Free Payload Distribution via MALDI Imaging Mass Spectrometry: Implications for Drug-to-Antibody Ratio Optimization in Antibody–Drug Conjugates	8
RNA Nanomedicine: Delivery Strategies and Applications	8
Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling	8
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	8
Recent Advances in Bioanalytical Methods for Quantification and Pharmacokinetic Analyses of Antibody–Drug Conjugates	8
Meta-Analysis of the Placebo Response in Chronic and Episodic Migraine: Insights from Migraine Preventive Drug Trials	8
Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters	8
Dacarbazine-loaded Bilayer Dissolving Microneedle Array Patch for Localized Delivery in Cutaneous Melanoma	8
A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities	8
Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products	7
In Vivo Clearance of Immune Complexes: Insights Into Human Drug/Anti-Drug Antibody Complex Clearance Dynamics	7
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	7
Lessons from CDER’s Quality Management Maturity Pilot Programs	7
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation	7
Impacts of Antibody Structure and Mixtures on Receptor Signaling for Antibody-Dependent Cellular Cytotoxicity	7
Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method	7
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	7
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety	7
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials	7
DNA Methylome and Transcriptome Study of Triterpenoid CDDO in TPA-Mediated Skin Carcinogenesis Model	7
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?	7
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays	7
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models	7
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications	7
Establishing the Human Duodenum Chip as a Surrogate for Effective Human Permeability: In Vitro and In Silico Assessment	7
Correction: Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling	7
From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation	7
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability	7
Does an Intradermal Vaccination for Monkeypox Make Sense?	7
Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models	7
Model-Informed Immunogenicity Assessment of Nivolumab as Monotherapy and in Combination with Ipilimumab	7
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	7
Prospects and Challenges of Catechins in Cardiovascular Disease	6
Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters	6
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder	6
Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants	6
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors	6
Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR	6
Correction: Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	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
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
Correction: Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis–Hastings Algorithm	6
Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary	6
Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies	6
Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning	6
Enhanced Nanoprecipitation Method for the Production of PLGA Nanoparticles for Oncology Applications	6
Recommendation of IV Dose Preparation Practices Using Closed System Transfer Devices (CSTD) for Accurate Dosing	6
Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development	6
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point	6
A Novel Oral Disintegrating Tablet Containing Aprepitant Nanocrystal Developed by Freeze-Drying Technology: An Effective Strategy to Enhance Aprepitant Bioavailability	6
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development	6
Reanalysis of Plasma Samples Collected from a CRO Reveals Possible Patterns of Bioanalytical Misconduct	6
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2	6
Machine Learning Predicts Drug Release Profiles and Kinetic Parameters Based on Tablets’ Formulations	6
Calibration Transfer Across Instrument Vendors for Bioprocess Raman Monitoring	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
Investigating Sulfotransferase Mediated Drug Interactions of Ethinylestradiol using a Physiologically Based Pharmacokinetic Model	6
Generating Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models	6
Investigations of Influence of Antibody Binding Kinetics on Tumor Distribution and Anti-Tumor Efficacy	6
Selection of Payloads for Antibody–Drug Conjugates Targeting Ubiquitously Expressed Tumor-Associated Antigens: a Case Study	6
Dose Optimization of ClpP Agonists Using an In Vitro Microfluidic Perfusion Platform and In Silico Pharmacokinetic-Pharmacodynamic Modeling	6
Simplifying Pharmacokinetics, Applying it to Drug and Dosage Form Development, and Making Drug Dosage Decisions in Clinical Medicine: The Adaptation of Kirchhoff’s Laws from Physics	6