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 2021-12-01 to 2025-12-01.)

Article	Citations
A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions	207
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease	80
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022	63
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy	51
Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy	46
Matching in Organ Impairment Studies: A Systematic Review of Accepted Methodologies	44
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal	35
Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network	32
Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics	30
A Novel Approach for Quantifying the Pharmacological Activity of T-Cell Engagers Utilizing In Vitro Time Course Experiments and Streamlined Data Analysis	30
The Drug Titration Paradox in the Presence of Intra-Individual Variation: Can we Estimate the True Concentration-Effect Relationship?	30
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate	29
A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models	29
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation	28
Evolution of Antidrug Antibody Assays During the Development of Anti-Tissue Factor Pathway Inhibitor Monoclonal Antibody Marstacimab	28
Machine Learning and Artificial Intelligence in Pharmaceutical Research and Development: a Review	25
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices	24
Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development	24
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent	24
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
Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine	23
Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method	23
Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance	22
Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories	22
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	22

Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker	22
Simultaneous Estimation of fm and FG Values Directly from Clinical Drug-Drug Interaction Study Data	21
Investigation of Antibody Pharmacokinetics in the Brain Following Intra-CNS Administration and Development of PBPK Model to Characterize the Data	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
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	20
A Quantitative Approach to Guiding Target Antigen Selection and Antibody Optimization in Recycling Antibody Discovery	20
Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs	20
Nomlabofusp, a Fusion Protein of Human Frataxin and a Cell Penetrant Peptide, Delivers Mature and Functional Frataxin into Mitochondria	19
PBPK Simulation-Based Evaluation of Ganciclovir Crystalluria Risk Factors: Effect of Renal Impairment, Old Age, and Low Fluid Intake	19
Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies	19
Lipid Nanoparticles for mRNA Delivery in Cancer Immunotherapy	18
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	18
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions	18
Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework	17
Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation	17
An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat	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
Drug Dissolution in Oral Drug Absorption: Workshop Report	17
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products	17
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans	16
Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study	15
Capillary-Mediated Vitrification: Preservation of mRNA at Elevated Temperatures	15
Regulatory Divergence in Narrow Therapeutic Index Drugs: A Comparative Review of the US, EU, Japan, Canada, and South Korea	15
Flux-Based Formulation Development—A Proof of Concept Study	15
Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions	15
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling	14
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	14
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing	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
A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume	14
Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper	14
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome	14
Insights from a Survey of Drug Formulation Experts: Challenges and Preferences in High-Concentration Subcutaneous Biologic Drug Development	14
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	13
ICH M10 Bioanalytical Method Validation Guideline-1 year Later	13
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	13
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	13
Comparison Between Pure Component Modeling Approaches for Monitoring Pharmaceutical Powder Blends with Near-Infrared Spectroscopy in Continuous Manufacturing Schemes	13
Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence	12
Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody	12
Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules	12
Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling	12
The Reference-Corrected Visual Predictive Check: A More Intuitive Diagnostic for Non-Linear Mixed Effects Models	12
Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model	12
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay	12
Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology	12
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submi	12
The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA	12

Pioneering Topical Ointment Intervention for Unprecedented Antimicrobial and Diabetic Wound Management with Phenylpropanoids and Nano-Silver	12
Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review	11
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	11
A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities	11
Nitrosamines Risk Assessment for Biopharmaceutics Classification System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokin	11
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	11
Dacarbazine-loaded Bilayer Dissolving Microneedle Array Patch for Localized Delivery in Cutaneous Melanoma	11
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents	11
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”	11
Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site	11
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route	11
RNA Nanomedicine: Delivery Strategies and Applications	10
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	10
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	10
Performance Evaluation of Montelukast Pediatric Formulations: Part II — a PBPK Modelling Approach	10
Recent Advances in Bioanalytical Methods for Quantification and Pharmacokinetic Analyses of Antibody–Drug Conjugates	10
Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling	10
Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method	10
Ensemble Machine Learning Approaches Based on Molecular Descriptors and Graph Convolutional Networks for Predicting the Efflux Activities of MDR1 and BCRP Transporters	10
Zwitterionic Polymer Coatings Enhance Gold Nanoparticle Stability and Uptake in Various Biological Environments	10
The Prevalence of Several Treatments in Preventing the Back Conversion of Acyl Glucuronide Metabolites in Abbreviated New Drug Applications	10
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety	9
Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products	9
Establishing the Human Duodenum Chip as a Surrogate for Effective Human Permeability: In Vitro and In Silico Assessment	9
From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation	8
Correction: Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation	8
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models	8
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	8
Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials	8
DNA Methylome and Transcriptome Study of Triterpenoid CDDO in TPA-Mediated Skin Carcinogenesis Model	8
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	8
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability	8
Does an Intradermal Vaccination for Monkeypox Make Sense?	8
Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning	7
Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models	7
Enhanced Nanoprecipitation Method for the Production of PLGA Nanoparticles for Oncology Applications	7
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?	7
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2	7
DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS	7
Model-Informed Immunogenicity Assessment of Nivolumab as Monotherapy and in Combination with Ipilimumab	7
Lessons from CDER’s Quality Management Maturity Pilot Programs	7
Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies	7
Recommendation of IV Dose Preparation Practices Using Closed System Transfer Devices (CSTD) for Accurate Dosing	7
Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters	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
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays	7
Cannabidiol and Hydroxypropyl-β-Cyclodextrin for the Development of Deflated Spherical-Shaped Inhalable Powder	7
Calibration Transfer Across Instrument Vendors for Bioprocess Raman Monitoring	7
Machine Learning Predicts Drug Release Profiles and Kinetic Parameters Based on Tablets’ Formulations	7
Correction: Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis–Hastings Algorithm	7
Prospects and Challenges of Catechins in Cardiovascular Disease	7
Considerations in Kp,uu,brain-based Strategy for Selecting CNS-targeted Drug Candidates with Sufficient Target Coverage and Substantial Pharmacodynamic Effect	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
Investigating Sulfotransferase Mediated Drug Interactions of Ethinylestradiol using a Physiologically Based Pharmacokinetic Model	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
Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants	6
Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient	6
Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies	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
Reanalysis of Plasma Samples Collected from a CRO Reveals Possible Patterns of Bioanalytical Misconduct	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
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development	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
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products	6
Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying	6
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point	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
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors	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
Investigations of Influence of Antibody Binding Kinetics on Tumor Distribution and Anti-Tumor Efficacy	6
Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine	6
Optimization of Peripheral Blood Mononuclear Cell Processing for Improved Clinical ELISpot Assay Performance	6
Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development	6