OOIR: Observatory of International Research

Papers

(The TQCC of AAPS Journal is 8. 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 2020-05-01 to 2024-05-01.)

Article	Citations
Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics	366
Recent Developments on Therapeutic and Diagnostic Approaches for COVID-19	289
Non-viral Vectors in Gene Therapy: Recent Development, Challenges, and Prospects	192
Remdesivir for Treatment of COVID-19: Combination of Pulmonary and IV Administration May Offer Aditional Benefit	89
Machine Learning and Artificial Intelligence in Pharmaceutical Research and Development: a Review	72
FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes	67
Use of Physiologically Based Pharmacokinetic (PBPK) Modeling for Predicting Drug-Food Interactions: an Industry Perspective	53
Protein Corona-Enabled Systemic Delivery and Targeting of Nanoparticles	42
Cannabinoid Interactions with Cytochrome P450 Drug Metabolism: a Full-Spectrum Characterization	41
A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metformin	41
Understanding Drug Delivery to the Brain Using Liposome-Based Strategies: Studies that Provide Mechanistic Insights Are Essential	39
γ-Hydroxybutyric Acid: Pharmacokinetics, Pharmacodynamics, and Toxicology	37
Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities	37
Physiologically Based Absorption Modelling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Entrectinib	35
Discovery of a Highly Selective Sigma-2 Receptor Ligand, 1-(4-(6,7-Dimethoxy-3,4-dihydroisoquinolin-2(1H)-yl)butyl)-3-methyl-1H-benzo[d]imidazol-2(3H)-one (CM398), with Drug-Like Properties and Antino	33
Considerations and Caveats when Applying Global Sensitivity Analysis Methods to Physiologically Based Pharmacokinetic Models	30
Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs	28
Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays	28
Amorphous Solid Dispersions Containing Residual Crystallinity: Competition Between Dissolution and Matrix Crystallization	27
Analytical Quality by Design, Life Cycle Management, and Method Control	27
A Quantitative Systems Pharmacology Model of T Cell Engager Applied to Solid Tumor	27
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models	26
Identification and Utilization of Biomarkers to Predict Response to Immune Checkpoint Inhibitors	26
Understanding Mechanisms of Food Effect and Developing Reliable PBPK Models Using a Middle-out Approach	25
Development and Application of a Physiologically-Based Pharmacokinetic Model to Predict the Pharmacokinetics of Therapeutic Proteins from Full-term Neonates to Adolescents	25

The Role of Alcohol Dehydrogenase in Drug Metabolism: Beyond Ethanol Oxidation	24
Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations	24
Investigating the Theoretical Basis for In Vitro–In Vivo Extrapolation (IVIVE) in Predicting Drug Metabolic Clearance and Proposing Future Experimental Pathways	23
Extracellular Vesicles in Oncology: from Immune Suppression to Immunotherapy	23
Intracellular ABCB1 as a Possible Mechanism to Explain the Synergistic Effect of Hydroxychloroquine-Azithromycin Combination in COVID-19 Therapy	23
Quality by Design–Based Assessment for Analytical Similarity of Adalimumab Biosimilar HLX03 to Humira®	23
In Vitro and In Vivo Efficacy of AZD3965 and Alpha-Cyano-4-Hydroxycinnamic Acid in the Murine 4T1 Breast Tumor Model	23
Applications of Nanoparticle-Antibody Conjugates in Immunoassays and Tumor Imaging	23
State of the Art and Uses for the Biopharmaceutics Drug Disposition Classification System (BDDCS): New Additions, Revisions, and Citation References	22
Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker	22
Application of Artificial Neural Networks in the Process Analytical Technology of Pharmaceutical Manufacturing—a Review	21
Development of Lipidoid Nanoparticles for siRNA Delivery to Neural Cells	21
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
In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report	20
There is Only One Valid Definition of Clearance: Critical Examination of Clearance Concepts Reveals the Potential for Errors in Clinical Drug Dosing Decisions	20
Employing Drug Delivery Strategies to Overcome Challenges Using TLR7/8 Agonists for Cancer Immunotherapy	19
Exosomes in Atherosclerosis, a Double-Edged Sword: Their Role in Disease Pathogenesis and Their Potential as Novel Therapeutics	19
Anti-drug Antibody Validation Testing and Reporting Harmonization	18
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	18
In Vitro to In Vivo Extrapolation of Metabolic Clearance for UGT Substrates Using Short-Term Suspension and Long-Term Co-cultured Human Hepatocytes	18
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	18
A Systematic Review of the Efforts and Hindrances of Modeling and Simulation of CAR T-cell Therapy	17
Evaluation of Excipient Risk in BCS Class I and III Biowaivers	16
Construction and Verification of Physiologically Based Pharmacokinetic Models for Four Drugs Majorly Cleared by Glucuronidation: Lorazepam, Oxazepam, Naloxone, and Zidovudine	16
Insights on Droplet Digital PCR–Based Cellular Kinetics and Biodistribution Assay Support for CAR-T Cell Therapy	16
Drug Absorption Parameters Obtained Using the Isolated Perfused Rat Lung Model Are Predictive of Rat In Vivo Lung Absorption	16
The Perspective of DMPK on Recombinant Adeno-Associated Virus-Based Gene Therapy: Past Learning, Current Support, and Future Contribution	16
The Influence of Drug Properties and Ontogeny of Transporters on Pediatric Renal Clearance through Glomerular Filtration and Active Secretion: a Simulation-Based Study	16
Assessment of the Kochak-Benet Equation for Hepatic Clearance for the Parallel-Tube Model: Relevance of Classic Clearance Concepts in PK and PBPK	16
International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines	15
Impact of Formulation Parameters on In Vitro Release from Long-Acting Injectable Suspensions	15
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus	15
Choroid Plexus and Drug Removal Mechanisms	15
Formoterol PLGA-PEG Nanoparticles Induce Mitochondrial Biogenesis in Renal Proximal Tubules	15
A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products	15
Age-Related Changes in Pediatric Physiology: Quantitative Analysis of Organ Weights and Blood Flows	15
Physiologically Based Pharmacokinetic Modeling of Oral Absorption, pH, and Food Effect in Healthy Volunteers to Drive Alpelisib Formulation Selection	14
Challenge-Enabled Machine Learning to Drug-Response Prediction	13
Modeling Temperature-Dependent Dermal Absorption and Clearance for Transdermal and Topical Drug Applications	13
Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?	13
Perspectives on Existing and Novel Alternative Intravaginal Probiotic Delivery Methods in the Context of Bacterial Vaginosis Infection	13
Multi-Well Array Culture of Primary Human Hepatocyte Spheroids for Clearance Extrapolation of Slowly Metabolized Compounds	13
Spinach and Chive for Kidney Tubule Engineering: the Limitations of Decellularized Plant Scaffolds and Vasculature	13
Capturing the Magic Bullet: Pharmacokinetic Principles and Modeling of Antibody-Drug Conjugates	12
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	12
Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories	12
Translational Modeling of Anticancer Efficacy to Predict Clinical Outcomes in a First-in-Human Phase 1 Study of MDM2 Inhibitor HDM201	12
Inhalable Nanoparticles/Microparticles of an AMPK and Nrf2 Activator for Targeted Pulmonary Drug Delivery as Dry Powder Inhalers	12
Impact of Magnesium Stearate Presence and Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties	12
Evaluation of Microparticulate (S)-4,5-Dihydroxy-2,3-pentanedione (DPD) as a Potential Vaccine Adjuvant	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
Bioanalytical Challenges in Support of Complex Modalities of Antibody-Based Therapeutics	12
Anthracycline-Induced Cardiotoxicity: Molecular Insights Obtained from Human-Induced Pluripotent Stem Cell–Derived Cardiomyocytes (hiPSC-CMs)	11
Oil-Immersion Flow Imaging Microscopy for Quantification and Morphological Characterization of Submicron Particles in Biopharmaceuticals	11
Land O’Lakes Workshop on Microsampling: Enabling Broader Adoption	11
Comparison of Fraction Unbound Between Liver Homogenate and Hepatocytes at 4°C	11
Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms	11
A Two-Pore Physiologically Based Pharmacokinetic Model to Predict Subcutaneously Administered Different-Size Antibody/Antibody Fragments	11
Skin Penetration Enhancement Strategies Used in the Development of Melanoma Topical Treatments	11
Dissolution Challenges Associated with the Surface pH of Drug Particles: Integration into Mechanistic Oral Absorption Modeling	11
Immunogenicity Risk Assessment for Multi-specific Therapeutics	11
Pharmacokinetic Analysis of Peptide-Modified Nanoparticles with Engineered Physicochemical Properties in a Mouse Model of Traumatic Brain Injury	11
HIV-1 Sanctuary Sites—the Role of Membrane-Associated Drug Transporters and Drug Metabolic Enzymes	11
Comparison of Canine and Human Physiological Factors: Understanding Interspecies Differences that Impact Drug Pharmacokinetics	11
Significance of the Vitamin D Receptor on Crosstalk with Nuclear Receptors and Regulation of Enzymes and Transporters	11
The Necessity of Using Changes in Absorption Time to Implicate Intestinal Transporter Involvement in Oral Drug-Drug Interactions	10
Population Pharmacokinetics of Sertraline in Healthy Subjects: a Model-Based Meta-analysis	10
The effects of all-trans retinoic acid on immune cells and its formulation design for vaccines	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
Current Approaches for Predicting Human PK for Small Molecule Development Candidates: Findings from the IQ Human PK Prediction Working Group Survey	10
PKPD Modeling and Dosing Considerations in Advanced Ovarian Cancer Patients Treated with Cisplatin-Based Intraoperative Intraperitoneal Chemotherapy	10
Using Physiologically Based Pharmacokinetic Modeling to Assess the Risks of Failing Bioequivalence Criteria: a Tale of Two Ibuprofen Products	10
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	10
Quantitative Evaluation of the Effect of Antigen Expression Level on Antibody–Drug Conjugate Exposure in Solid Tumor	10
Nanotechnology-Driven Cell-Based Therapies in Regenerative Medicine	10
In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes	10
Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group	10
An Integrated Analysis of Dostarlimab Immunogenicity	9
Bioavailability Enhancement and Food Effect Elimination of Abiraterone Acetate by Encapsulation in Surfactant-Enriched Oil Marbles	9
Prediction of glomerular filtration rate maturation across preterm and term neonates and young infants using inulin as marker	9
Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid Dispersion Formulations	9
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine: Current Status and Emerging Trends	9
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy	9
The Nano-War Against Complement Proteins	9
Iontophoresis to Overcome the Challenge of Nail Permeation: Considerations and Optimizations for Successful Ungual Drug Delivery	9
In Vitro to In Vivo Extrapolation Linked to Physiologically Based Pharmacokinetic Models for Assessing the Brain Drug Disposition	9
Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics	9
A Physiologically Based Pharmacokinetic Model of Vismodegib: Deconvoluting the Impact of Saturable Plasma Protein Binding, pH-Dependent Solubility and Nonsink Permeation	9
Elucidating the Effect of Fine Lactose Ratio on the Rheological Properties and Aerodynamic Behavior of Dry Powder for Inhalation	9
Role of HIV and Antiretroviral Therapy on the Expression of Placental Transporters in Women with HIV	9
Metabolism of Speciociliatine, an Overlooked Kratom Alkaloid for its Potential Pharmacological Effects	8
Nfe2l2 Regulates Metabolic Rewiring and Epigenetic Reprogramming in Mediating Cancer Protective Effect by Fucoxanthin	8
Usage of Compartmental Models in Predicting COVID-19 Outbreaks	8
Nano-delivery of Gemcitabine Derivative as a Therapeutic Strategy in a Desmoplastic KRAS Mutant Pancreatic Cancer	8
Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies	8
Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk	8
A Systematic Approach for Liposome and Lipodisk Preclinical Formulation Development by Microfluidic Technology	8
Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions	8
Evidence-Based Guidelines for Drug Interaction Studies: Model-Informed Time Course of Intestinal and Hepatic CYP3A4 Inhibition by Clarithromycin	8
Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates	8