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

Article	Citations
Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics	415
Recent Developments on Therapeutic and Diagnostic Approaches for COVID-19	314
Non-viral Vectors in Gene Therapy: Recent Development, Challenges, and Prospects	241
Machine Learning and Artificial Intelligence in Pharmaceutical Research and Development: a Review	96
FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes	78
Understanding Drug Delivery to the Brain Using Liposome-Based Strategies: Studies that Provide Mechanistic Insights Are Essential	54
Cannabinoid Interactions with Cytochrome P450 Drug Metabolism: a Full-Spectrum Characterization	50
γ-Hydroxybutyric Acid: Pharmacokinetics, Pharmacodynamics, and Toxicology	43
Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities	42
Analytical Quality by Design, Life Cycle Management, and Method Control	37
Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs	33
State of the Art and Uses for the Biopharmaceutics Drug Disposition Classification System (BDDCS): New Additions, Revisions, and Citation References	31
Amorphous Solid Dispersions Containing Residual Crystallinity: Competition Between Dissolution and Matrix Crystallization	31
Applications of Nanoparticle-Antibody Conjugates in Immunoassays and Tumor Imaging	29
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models	29
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays	29
The Role of Alcohol Dehydrogenase in Drug Metabolism: Beyond Ethanol Oxidation	28
Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review	28
Extracellular Vesicles in Oncology: from Immune Suppression to Immunotherapy	28
Anti-drug Antibody Validation Testing and Reporting Harmonization	26
Albumin-Mediated Uptake Improves Human Clearance Prediction for Hepatic Uptake Transporter Substrates Aiding a Mechanistic In Vitro-In Vivo Extrapolation (IVIVE) Strategy in Discovery Research	26
Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach	25
Development of Lipidoid Nanoparticles for siRNA Delivery to Neural Cells	24
Exosomes in Atherosclerosis, a Double-Edged Sword: Their Role in Disease Pathogenesis and Their Potential as Novel Therapeutics	24
Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker	22

There is Only One Valid Definition of Clearance: Critical Examination of Clearance Concepts Reveals the Potential for Errors in Clinical Drug Dosing Decisions	22
A Systematic Review of the Efforts and Hindrances of Modeling and Simulation of CAR T-cell Therapy	22
Impact of Formulation Parameters on In Vitro Release from Long-Acting Injectable Suspensions	20
Multi-Well Array Culture of Primary Human Hepatocyte Spheroids for Clearance Extrapolation of Slowly Metabolized Compounds	20
Translational CNS Steady-State Drug Disposition Model in Rats, Monkeys, and Humans for Quantitative Prediction of Brain-to-Plasma and Cerebrospinal Fluid-to-Plasma Unbound Concentration Ratios	20
Employing Drug Delivery Strategies to Overcome Challenges Using TLR7/8 Agonists for Cancer Immunotherapy	20
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective	20
The Perspective of DMPK on Recombinant Adeno-Associated Virus-Based Gene Therapy: Past Learning, Current Support, and Future Contribution	19
In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes	18
Choroid Plexus and Drug Removal Mechanisms	18
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines	18
Insights on Droplet Digital PCR–Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy	18
Evaluation of Excipient Risk in BCS Class I and III Biowaivers	17
Assessment of the Kochak-Benet Equation for Hepatic Clearance for the Parallel-Tube Model: Relevance of Classic Clearance Concepts in PK and PBPK	17
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products	16
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Ph	16
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus	16
Formoterol PLGA-PEG Nanoparticles Induce Mitochondrial Biogenesis in Renal Proximal Tubules	16
Age-Related Changes in Pediatric Physiology: Quantitative Analysis of Organ Weights and Blood Flows	16
Immunogenicity Risk Assessment for Multi-specific Therapeutics	15
Perspectives on Existing and Novel Alternative Intravaginal Probiotic Delivery Methods in the Context of Bacterial Vaginosis Infection	15
Evaluation of Microparticulate (S)-4,5-Dihydroxy-2,3-pentanedione (DPD) as a Potential Vaccine Adjuvant	15
Nanotechnology-Driven Cell-Based Therapies in Regenerative Medicine	15
Comparison of Canine and Human Physiological Factors: Understanding Interspecies Differences that Impact Drug Pharmacokinetics	15
Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms	15
Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories	15
Spinach and Chive for Kidney Tubule Engineering: the Limitations of Decellularized Plant Scaffolds and Vasculature	15
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy	14
Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid Dispersion Formulations	14
Current Approaches for Predicting Human PK for Small Molecule Development Candidates: Findings from the IQ Human PK Prediction Working Group Survey	14
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	14
A Two-Pore Physiologically Based Pharmacokinetic Model to Predict Subcutaneously Administered Different-Size Antibody/Antibody Fragments	14
Translational Modeling of Anticancer Efficacy to Predict Clinical Outcomes in a First-in-Human Phase 1 Study of MDM2 Inhibitor HDM201	14
Anthracycline-Induced Cardiotoxicity: Molecular Insights Obtained from Human-Induced Pluripotent Stem Cell–Derived Cardiomyocytes (hiPSC-CMs)	13
Inhalable Nanoparticles/Microparticles of an AMPK and Nrf2 Activator for Targeted Pulmonary Drug Delivery as Dry Powder Inhalers	13
Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters	13
Quantitative Evaluation of the Effect of Antigen Expression Level on Antibody–Drug Conjugate Exposure in Solid Tumor	13
Skin Penetration Enhancement Strategies Used in the Development of Melanoma Topical Treatments	13
In Vitro to In Vivo Extrapolation Linked to Physiologically Based Pharmacokinetic Models for Assessing the Brain Drug Disposition	13
Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?	13
The Nano-War Against Complement Proteins	13
Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop	12
Comparison of the ELISA and ECL Assay for Vedolizumab Anti-drug Antibodies: Assessing the Impact on Pharmacokinetics and Safety Outcomes of the Phase 3 GEMINI Trials	12
Metabolism of Speciociliatine, an Overlooked Kratom Alkaloid for its Potential Pharmacological Effects	12
Dosing Recommendations for Vancomycin in Children and Adolescents with Varying Levels of Obesity and Renal Dysfunction: a Population Pharmacokinetic Study in 1892 Children Aged 1–18 Years	12
Dissolution Challenges Associated with the Surface pH of Drug Particles: Integration into Mechanistic Oral Absorption Modeling	12
Pharmacokinetic Analysis of Peptide-Modified Nanoparticles with Engineered Physicochemical Properties in a Mouse Model of Traumatic Brain Injury	12
The effects of all-trans retinoic acid on immune cells and its formulation design for vaccines	12
A Systematic Approach for Liposome and Lipodisk Preclinical Formulation Development by Microfluidic Technology	11
Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group	11

Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies	11
Elucidating the Effect of Fine Lactose Ratio on the Rheological Properties and Aerodynamic Behavior of Dry Powder for Inhalation	11
Oil-Immersion Flow Imaging Microscopy for Quantification and Morphological Characterization of Submicron Particles in Biopharmaceuticals	11
Iontophoresis to Overcome the Challenge of Nail Permeation: Considerations and Optimizations for Successful Ungual Drug Delivery	11
An Integrated Analysis of Dostarlimab Immunogenicity	10
Assessment of Drug Delivery Kinetics to Epidermal Targets In Vivo	10
Microfluidic-Generated Immunomodulatory Nanoparticles and Formulation-Dependent Effects on Lipopolysaccharide-Induced Macrophage Inflammation	10
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends	10
Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review	10
Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine	10
Evidence-Based Guidelines for Drug Interaction Studies: Model-Informed Time Course of Intestinal and Hepatic CYP3A4 Inhibition by Clarithromycin	9
Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein	9
Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates	9
Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry	9
Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium	9
Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics	9
Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker	9
Lipid Nanoparticle-Enabled Intracellular Delivery of Prime Editors	9
The Evolution of Single-Cell Analysis and Utility in Drug Development	9
Navigating Through Cell-Based In vitro Models Available for Prediction of Intestinal Permeability and Metabolism: Are We Ready for 3D?	9
Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy	8
The Uses and Advantages of Kirchhoff’s Laws vs. Differential Equations in Pharmacology, Pharmacokinetics, and (Even) Chemistry	8
Drug Dissolution in Oral Drug Absorption: Workshop Report	8
Model for Long Acting Injectables (Depot Formulation) Based on Pharmacokinetics and Physical Chemical Properties	8
Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submi	8
Nfe2l2 Regulates Metabolic Rewiring and Epigenetic Reprogramming in Mediating Cancer Protective Effect by Fucoxanthin	8
Exploring the Relationship of Drug BCS Classification, Food Effect, and Gastric pH-Dependent Drug Interactions	8
Human Fetal Liver Metabolism of Oxycodone Is Mediated by CYP3A7	8
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications	8
Monoclonal Antibody Reagent Stability and Expiry Recommendation Combining Experimental Data with Mathematical Modeling	8
Predicting Human Bioavailability of Subcutaneously Administered Fusion Proteins and Monoclonal Antibodies Using Human Intravenous Clearance or Antibody Isoelectric Point	8
Biomarker Assay Validation by Mass Spectrometry	8
Immunoglobulin G Is a Novel Substrate for the Endocytic Protein Megalin	8
Neutralizing Antibody Validation Testing and Reporting Harmonization	8
Recent Advances in 3D Printing for Parenteral Applications	7
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development	7
PBPK Simulation-Based Evaluation of Ganciclovir Crystalluria Risk Factors: Effect of Renal Impairment, Old Age, and Low Fluid Intake	7
Real-World Evidence of the Top 100 Prescribed Drugs in the USA and Their Potential for Drug Interactions with Nirmatrelvir; Ritonavir	7
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	7
An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow	7
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines	7
Incorporating Breastfeeding-Related Variability with Physiologically Based Pharmacokinetic Modeling to Predict Infant Exposure to Maternal Medication Through Breast Milk: a Workflow Applied to Lamotri	7
Estimation of Ontogeny Functions for Renal Transporters Using a Combined Population Pharmacokinetic and Physiology-Based Pharmacokinetic Approach: Application to OAT1,3	7
Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations	7
Direct Comparison of the Prediction of the Unbound Brain-to-Plasma Partitioning Utilizing Machine Learning Approach and Mechanistic Neuropharmacokinetic Model	7
Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review	7
Reactive Oxygen Species–Responsive Celastrol-Loaded Bilirubin Nanoparticles for the Treatment of Rheumatoid Arthritis	7
Factors Affecting Successful Extrapolation of Ibuprofen Exposure from Adults to Pediatric Populations After Oral Administration of a Pediatric Aqueous Suspension	7