OOIR: Observatory of International Research

Papers

(The TQCC of AAPS Journal is 7. 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 2022-08-01 to 2026-08-01.)

Article	Citations
A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models	63
Application of a Modified In Situ Perfusion Model to Quantify Intestinal Drug Excretion and Transporter-Mediated Interactions after Intravenous Administration	54
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation	45
The Drug Titration Paradox in the Presence of Intra-Individual Variation: Can we Estimate the True Concentration-Effect Relationship?	44
Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics	44
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate	42
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease	42
Matching in Organ Impairment Studies: A Systematic Review of Accepted Methodologies	35
A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions	34
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network	33
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal	30
Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy	30
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022	30
Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab	29
Development and Implementation of a Hinderance-based In Vitro Model for Porous Membranes	28
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	28
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method	27
Perspectives on PCR-Based Cellular Kinetics and Biodistribution Analysis for Emerging Adoptive Cell Therapies	27
Pharmacokinetics of Inhibitors of Succinyl-CoA:3-Ketoacid CoA Transferase in Sprague–Dawley Rats, and the Effect of a High-Fat Diet	27
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices	26
Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine	26
Best Practices for Performing Analytical and Functional Biosimilarity Assessment of Recombinant Monoclonal Antibody Biosimilars	26
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent	26
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	25
Industry Practices in Oligonucleotide Tissue Biodistribution Assessment: An IQ consortium Cross-Industry Survey of Current Approaches and Emerging Trends	25

HLA Class II Alleles DRB111:01 and DQB103:01 Unmask Immunogenetic Susceptibility to Anti-Nivolumab Antibodies in Combination with Ipilimumab	23
Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance	22
Investigation of 2,4 Di-tert-butylphenol Leaching from Multidose Ophthalmic Devices into Tacrolimus Micellar Formulations	21
A Bottom-up Approach for Mutant and Wild Type Collies Using Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using Loperamide	21
Model-informed Drug Development (MIDD) Approach to Support Biopharmaceutical Development of Iberdomide	21
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
Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies	19
Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability	18
Nomlabofusp, a Fusion Protein of Human Frataxin and a Cell Penetrant Peptide, Delivers Mature and Functional Frataxin into Mitochondria	18
Quantitative Investigation of ATP Switch Concept of STA551 Through Combined In Vivo Tissue Distribution Studies and Physiologically Based Pharmacokinetic Modeling	18
Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs	18
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
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data	17
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines	17
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans	16
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions	16
Lipid Nanoparticles for mRNA Delivery in Cancer Immunotherapy	16
Theoretical and Numerical Investigation of the Consistency of Model Comparisons in Pharmacometrics	15
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	15
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework	15
Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation	15
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products	15
Drug Dissolution in Oral Drug Absorption: Workshop Report	15
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
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	14
Innovative In Vitro-In Silico Platform for Dose–Response Modeling in Canine Bladder Cancer: A 3D Organoid- and Mathematics-Based Approach	14
New Frontiers in ADC Analysis: Advances in Chromatography, Electrophoresis, and Mass Spectrometry	14
Regulatory Divergence in Narrow Therapeutic Index Drugs: A Comparative Review of the US, EU, Japan, Canada, and South Korea	13
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome	13
Target Abundance in Pharmacological Target-Mediated Drug Disposition (TMDD) for Small Molecules — A Proteomics Approach	13
Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper	12
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	12
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing	12
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling	12
ICH M10 Bioanalytical Method Validation Guideline-1 year Later	11
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	11
Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody	11
Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology	11
Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions	11
A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume	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
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study	11
Insights from a Survey of Drug Formulation Experts: Challenges and Preferences in High-Concentration Subcutaneous Biologic Drug Development	11
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay	11
Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules	11
A Design of Experiments and Risk Management-Driven Analytical Platform for Charge Variant Analysis of Therapeutic Antibodies by Imaged Capillary Isoelectric Focusing	10
Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling	10
Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver	10
Biodistribution of Cerivastatin, Repaglinide, Glyburide, Rosuvastatin, and Valsartan in Cynomolgus Monkeys and PBPK Analysis	10

Effect of Incentivizing Pediatric Studies on the Development of Pediatric-Friendly Formulations	10
Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	10
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA	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
Nanotechnology-enhanced Natural Products for Cancer Chemoprevention: Molecular Mechanisms and Clinical Translation	10
The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models	10
In vivo Predictive Dissolution Test Using Biorelevant Bicarbonate Buffer for High-dose Free Acid Drug	9
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents	9
Spatiotemporal Profiling of Intratumoral Free Payload Distribution via MALDI Imaging Mass Spectrometry: Implications for Drug-to-Antibody Ratio Optimization in Antibody–Drug Conjugates	9
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”	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
De-risking Biopharma Asset Acquisition: Towards a Quantitative Framework for Strategic Decision-making	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
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
Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review	9
Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling	9
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials	8
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route	8
Nitrosamines Risk Assessment for Biopharmaceutics Classification System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokin	8
Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters	8
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications	8
Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products	8
Dacarbazine-loaded Bilayer Dissolving Microneedle Array Patch for Localized Delivery in Cutaneous Melanoma	8
Recent Advances in Bioanalytical Methods for Quantification and Pharmacokinetic Analyses of Antibody–Drug Conjugates	8
PBPK Modelling of PROTACs: Learnings from ARV-110 as a Case Example	8
RNA Nanomedicine: Delivery Strategies and Applications	8
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	8
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	8
Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site	8
A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities	8
Meta-Analysis of the Placebo Response in Chronic and Episodic Migraine: Insights from Migraine Preventive Drug Trials	8
Establishing the Human Duodenum Chip as a Surrogate for Effective Human Permeability: In Vitro and In Silico Assessment	8
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
Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants	7
Prospects and Challenges of Catechins in Cardiovascular Disease	7
Enhanced Nanoprecipitation Method for the Production of PLGA Nanoparticles for Oncology Applications	7
Machine Learning Predicts Drug Release Profiles and Kinetic Parameters Based on Tablets’ Formulations	7
Does an Intradermal Vaccination for Monkeypox Make Sense?	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
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation	7
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability	7
Lessons from CDER’s Quality Management Maturity Pilot Programs	7
Investigating Sulfotransferase Mediated Drug Interactions of Ethinylestradiol using a Physiologically Based Pharmacokinetic Model	7
Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning	7
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?	7
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder	7
Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models	7
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models	7
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety	7
In Vivo Clearance of Immune Complexes: Insights Into Human Drug/Anti-Drug Antibody Complex Clearance Dynamics	7
Model-Informed Immunogenicity Assessment of Nivolumab as Monotherapy and in Combination with Ipilimumab	7
IFN-γ/IL-2 Double-Color FluoroSpot Assay for Monitoring Human Primary T Cell Activation: Validation, Inter-Laboratory Comparison, and Recommendations for Clinical Studies	7
High Concordance of Total Antibody and Transduction Inhibition Assays Enables Replacement of Cell-Based Antibody Testing for Preexisting Anti-AAV Immunity in Cynomolgus Monkey	7
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2	7
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays	7
Calibration Transfer Across Instrument Vendors for Bioprocess Raman Monitoring	7
Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies	7
DNA Methylome and Transcriptome Study of Triterpenoid CDDO in TPA-Mediated Skin Carcinogenesis Model	7
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	7