OOIR: Observatory of International Research

Papers

(The TQCC of Clinical Pharmacology & Therapeutics 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
An Evidence‐Based Framework for Evaluating Pharmacogenomics Knowledge for Personalized Medicine	374
Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2D6, OPRM1, and COMT Genotypes and Select Opioid Therapy	236
Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 Genotype and Clopidogrel Therapy: 2022 Update	215
The Clinical Pharmacogenetics Implementation Consortium Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and Statin‐Associated Musculoskeletal Symptoms	161
From Therapeutic Drug Monitoring to Model‐Informed Precision Dosing for Antibiotics	158
Recommendations for the Management of Drug–Drug Interactions Between the COVID‐19 Antiviral Nirmatrelvir/Ritonavir (Paxlovid) and Comedications	147
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth	110
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A Genotypes and Serotonin Reuptake Inhibitor Antide	103
Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value	102
Pharmacogenetics at Scale: An Analysis of the UK Biobank	92
Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID‐19 Trial of Nirmatrelvir	89
The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications	83
Pharmacogene Variation Consortium: A Global Resource and Repository for Pharmacogene Variation	80
Mechanistic Modeling of SARS‐CoV‐2 and Other Infectious Diseases and the Effects of Therapeutics	75
Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Study in Healthy Subjects	74
Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective	70
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?	70
Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)	62
Liquid Biopsy Enables Quantification of the Abundance and Interindividual Variability of Hepatic Enzymes and Transporters	60
Use of Real‐World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design	60
Cannabidiol and Abnormal Liver Chemistries in Healthy Adults: Results of a Phase I Clinical Trial	59
Inflammation, Lifestyle Factors, and the Microbiome‐Gut‐Brain Axis: Relevance to Depression and Antidepressant Action	59
The Treatment of Tuberculosis	59
Cost Effectiveness of Pharmacogenetic Testing for Drugs with Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines: A Systematic Review	56
Tacrolimus Exposure Prediction Using Machine Learning	55

Association Between FIASMAs and Reduced Risk of Intubation or Death in Individuals Hospitalized for Severe COVID‐19: An Observational Multicenter Study	53
Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database	52
A Model Averaging/Selection Approach Improves the Predictive Performance of Model‐Informed Precision Dosing: Vancomycin as a Case Study	51
Impact of Acute Inflammation on Cytochromes P450 Activity Assessed by the Geneva Cocktail	51
A New Era in Pharmacovigilance: Toward Real‐World Data and Digital Monitoring	50
How to Integrate CYP2D6 Phenoconversion Into Clinical Pharmacogenetics: A Tutorial	50
Clinical Pharmacogenetics Implementation Consortium Guideline for the Use of Aminoglycosides Based on MT‐RNR1 Genotype	50
Pharmacogenomic Testing and Depressive Symptom Remission: A Systematic Review and Meta‐Analysis of Prospective, Controlled Clinical Trials	49
Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID‐19, in Subjects With Renal Impairment	49
Association Between Use of Pharmacokinetic‐Interacting Drugs and Effectiveness and Safety of Direct Acting Oral Anticoagulants: Nested Case‐Control Study	49
Model‐Informed Drug Development for Anti‐Infectives: State of the Art and Future	48
Exploring the Use of Serum‐Derived Small Extracellular Vesicles as Liquid Biopsy to Study the Induction of Hepatic Cytochromes P450 and Organic Anion Transporting Polypeptides	46
Real‐World Infliximab Pharmacokinetic Study Informs an Electronic Health Record‐Embedded Dashboard to Guide Precision Dosing in Children with Crohn’s Disease	44
Genomewide Association Studies in Pharmacogenomics	44
Individualized Dosing of Fluoropyrimidine‐Based Chemotherapy to Prevent Severe Fluoropyrimidine‐Related Toxicity: What Are the Options?	42
Countermeasures for Preventing and Treating Opioid Overdose	41
Moving Pharmacogenetics Into Practice: It’s All About the Evidence!	41
A Tutorial for Pharmacogenomics Implementation Through End‐to‐End Clinical Decision Support Based on Ten Years of Experience from PREDICT	40
Impact of SARS‐CoV‐2 Infection (COVID‐19) on Cytochromes P450 Activity Assessed by the Geneva Cocktail	40
PharmVar GeneFocus: CYP2B6	40
PharmVar GeneFocus: CYP2C9	40
Opportunity for Genotype‐Guided Prescribing Among Adult Patients in 11 US Health Systems	39
COVIDOSE: A Phase II Clinical Trial of Low‐Dose Tocilizumab in the Treatment of Noncritical COVID‐19 Pneumonia	39
Dihydropyrimidine Dehydrogenase Phenotyping Using Pretreatment Uracil: A Note of Caution Based on a Large Prospective Clinical Study	37
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective	36
StellarPGx: A Nextflow Pipeline for Calling Star Alleles in Cytochrome P450 Genes	36
Regulation of Drug Transport Proteins—From Mechanisms to Clinical Impact: A White Paper on Behalf of the International Transporter Consortium	35
A Novel CYP2C‐Haplotype Associated With Ultrarapid Metabolism of Escitalopram	35
The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework	35
Immunopharmacogenomics: Mechanisms of HLA‐Associated Drug Reactions	35
Genetic Risk Factors in Drug‐Induced Liver Injury Due to Isoniazid‐Containing Antituberculosis Drug Regimens	34
Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness	34
Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making	34
Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021	34
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding	34
Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates?	34
Biomarker‐Guided Individualization of Antibiotic Therapy	33
Clinical and Molecular Perspectives on Inflammation‐Mediated Regulation of Drug Metabolism and Transport	33
Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019	32
IL‐17 Inhibitors and Inflammatory Bowel Diseases: A Postmarketing Study in Vigibase	32
Benefit‐Risk Assessment of Off‐Label Drug Use in Children: The Bravo Framework	31
Pharmacogenomic Clinical Decision Support: A Review, How‐to Guide, and Future Vision	31
Model‐Based Drug–Drug Interaction Extrapolation Strategy From Adults to Children: Risdiplam in Pediatric Patients With Spinal Muscular Atrophy	31
Artificial Intelligence for Unstructured Healthcare Data: Application to Coding of Patient Reporting of Adverse Drug Reactions	31
Pharmacogenetics of Bleeding and Thromboembolic Events in Direct Oral Anticoagulant Users	30
Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan	30
Sex and Gender Differences in Clinical Pharmacology: Implications for Transgender Medicine	30
Transporters in Drug Development: International Transporter Consortium Update on Emerging Transporters of Clinical Importance	30
Pharmacokinetics and Pharmacodynamics of Oral Psilocybin Administration in Healthy Participants	30
Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID‐19 Infection	29

Clinical Implications of Altered Drug Transporter Abundance/Function and PBPK Modeling in Specific Populations: An ITC Perspective	29
The Friends of Cancer Research Real‐World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies	28
Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy	28
Continuous Learning in Model‐Informed Precision Dosing: A Case Study in Pediatric Dosing of Vancomycin	28
NT‐proBNP Qualifies as a Surrogate for Clinical End Points in Heart Failure	28
Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis	27
Perspectives on Virtual (Remote) Clinical Trials as the “New Normal” to Accelerate Drug Development	27
Real‐World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID‐19	27
Mycophenolic Acid Exposure Prediction Using Machine Learning	27
Avoiding Tacrolimus Underexposure and Overexposure with a Dosing Algorithm for Renal Transplant Recipients: A Single Arm Prospective Intervention Trial	27
Roadmap to 2030 for Drug Evaluation in Older Adults	27
Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men	26
Assuring Access to Safe Medicines in Pregnancy and Breastfeeding	26
Evaluation of the CYP2D6 Haplotype Activity Scores Based on Metabolic Ratios of 4,700 Patients Treated With Three Different CYP2D6 Substrates	26
Population Pharmacokinetics of Trastuzumab Deruxtecan in Patients With HER2‐Positive Breast Cancer and Other Solid Tumors	26
Physiologically Based Precision Dosing Approach for Drug‐Drug‐Gene Interactions: A Simvastatin Network Analysis	26
A Systematic Review and Analysis of the Use of Polygenic Scores in Pharmacogenomics	26
Systematic Review and Patient‐Level Meta‐Analysis of SARS‐CoV‐2 Viral Dynamics to Model Response to Antiviral Therapies	26
New and Emerging Research on Solute Carrier and ATP Binding Cassette Transporters in Drug Discovery and Development: Outlook From the International Transporter Consortium	26
Features of Inflammatory Heart Reactions Following mRNA COVID‐19 Vaccination at a Global Level	26
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease	26
First‐in‐Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID‐19	26
Pharmacogenetic Predictors of Cannabidiol Response and Tolerability in Treatment‐Resistant Epilepsy	25
Drug Disposition Protein Quantification in Matched Human Jejunum and Liver From Donors With Obesity	25
Biomarker‐Informed Model‐Based Risk Assessment of Organic Anion Transporting Polypeptide 1B Mediated Drug‐Drug Interactions	25
Drug‐Drug Interactions Involving Renal OCT2/MATE Transporters: Clinical Risk Assessment May Require Endogenous Biomarker‐Informed Approach	25
Liquid Biopsy for Patient Characterization in Cardiovascular Disease: Verification against Markers of Cytochrome P450 and P‐Glycoprotein Activities	25
Assessing Transporter‐Mediated Natural Product‐Drug Interactions Via In vitro‐In Vivo Extrapolation: Clinical Evaluation With a Probe Cocktail	25
Blockade of Organic Anion Transport in Humans After Treatment With the Drug Probenecid Leads to Major Metabolic Alterations in Plasma and Urine	24
Development of a Translational Model to Assess the Impact of Opioid Overdose and Naloxone Dosing on Respiratory Depression and Cardiac Arrest	24
Exposure‐Response Relationships in Patients With HER2‐Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan	24
PharmVar GeneFocus: SLCO1B1	24
Rational Clinical Dose Selection of Adeno‐Associated Virus‐Mediated Gene Therapy Based on Allometric Principles	24
Dihydropyrimidine Dehydrogenase Deficiency and Implementation of UpfrontDPYDGenotyping	23
Translational Pharmacogenomics: Discovery, Evidence Synthesis and Delivery of Race‐Conscious Medicine	23
Impact of Hepatic CYP3A4 Ontogeny Functions on Drug–Drug Interaction Risk in Pediatric Physiologically‐Based Pharmacokinetic/Pharmacodynamic Modeling: Critical Literature Review and Ivabradine Case St	23
Depletion of LAG‐3⁺ T Cells Translated to Pharmacology and Improvement in Psoriasis Disease Activity: A Phase I Randomized Study of mAb GSK2831781	23
Collaborative Platform Trials to Fight COVID‐19: Methodological and Regulatory Considerations for a Better Societal Outcome	23
Sex‐Specific Classification of Drug‐Induced Torsade de Pointes Susceptibility Using Cardiac Simulations and Machine Learning	22
Pivotal Role of Translation in Anti‐Infective Development	22
Coprescription of Opioids With Other Medications and Risk of Opioid Overdose	22
The Drug Titration Paradox: Correlation of More Drug With Less Effect in Clinical Data	22
Model‐Informed Drug Development for Antimicrobials: Translational PK and PK/PD Modeling to Predict an Efficacious Human Dose for Apramycin	22
The Lymph Node Reservoir: Physiology, HIV Infection, and Antiretroviral Therapy	22
Performance of Plasma Coproporphyrin I and III as OATP1B1 Biomarkers in Humans	22
Circadian Variation in Efficacy of Medications	21
Quantification of Proteins Involved in Intestinal Epithelial Handling of Xenobiotics	21
Prediction of Clinical Trials Outcomes Based on Target Choice and Clinical Trial Design with Multi‐Modal Artificial Intelligence	21
Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations	20
Drugs in COVID‐19 Clinical Trials: Predicting Transporter‐Mediated Drug‐Drug Interactions Using In Vitro Assays and Real‐World Data	20
Genomewide Association Study of Simvastatin Pharmacokinetics	20
The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States	20
PharmVar GeneFocus: CYP3A5	20
A Drug‐Drug Interaction Study Evaluating the Effect of Givosiran, a Small Interfering Ribonucleic Acid, on Cytochrome P450 Activity in the Liver	20
Effectiveness of Intermittent Preventive Treatment With Dihydroartemisinin‐Piperaqunine Against Malaria in Pregnancy in Tanzania: A Randomized Controlled Trial	20
A Useful and Sustainable Role for N‐of‐1 Trials in the Healthcare Ecosystem	20
Anticoagulant Treatment Regimens in Patients With Covid‐19: A Meta‐Analysis	20
OX40L Inhibition Suppresses KLH‐driven Immune Responses in Healthy Volunteers: A Randomized Controlled Trial Demonstrating Proof‐of‐Pharmacology for KY1005	20
Physiologically‐Based Pharmacokinetic Modeling of Remdesivir and Its Metabolites to Support Dose Selection for the Treatment of Pediatric Patients With COVID‐19	20
Effect of Cyclosporin A and Impact of Dose Staggering on OATP1B1/1B3 Endogenous Substrates and Drug Probes for Assessing Clinical Drug Interactions	20
Can In Vitro–In Vivo Extrapolation Be Successful? Recognizing the Incorrect Clearance Assumptions	20
Key Challenges in Providing Effective Antibiotic Therapy for Critically Ill Patients with Bacterial Sepsis and Septic Shock	20
Lorlatinib Exposure‐Response Analyses for Safety and Efficacy in a Phase I/II Trial to Support Benefit–Risk Assessment in Non‐Small Cell Lung Cancer	20
Model‐Based Quantification of Impact of Genetic Polymorphisms and Co‐Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer	19
Computational Tools to Assess the Functional Consequences of Rare and Noncoding Pharmacogenetic Variability	19
Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting	19
Successful Prediction of Human Steady‐State Unbound Brain‐to‐Plasma Concentration Ratio of P‐gp Substrates Using the Proteomics‐Informed Relative Expression Factor Approach	19
Toward Consensus on Correct Interpretation of Protein Binding in Plasma and Other Biological Matrices for COVID‐19 Therapeutic Development	19
Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency	19
Strategies and Recommendations for Using a Data‐Driven and Risk‐Based Approach in the Selection of First‐in‐Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutica	19
Pivotal Dose of Pembrolizumab: A Dose‐Finding Strategy for Immuno‐Oncology	19
Physiologically‐Based Pharmacokinetic Model of Morphine and Morphine‐3‐Glucuronide in Nonalcoholic Steatohepatitis	18
Clinical Relevance of Hepatic and Renal P‐gp/BCRP Inhibition of Drugs: An International Transporter Consortium Perspective	18
Physiologically‐Based Pharmacokinetic‐Led Guidance for Patients With Cystic Fibrosis Taking Elexacaftor‐Tezacaftor‐Ivacaftor With Nirmatrelvir‐Ritonavir for the Treatment of COVID‐19	18
Expanded Clinical Pharmacogenetics Implementation Consortium Guideline for Medication Use in the Context of G6PD Genotype	18
Transferability of Ancestry‐Specific and Cross‐Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations	18
Enhancing Diversity and Inclusion in Clinical Trials	18
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020	18
Diversity, Equity, and Inclusion in Clinical Research: A Path Toward Precision Health for Everyone	18
Japan’s Drug Regulation During the COVID‐19 Pandemic: Lessons From a Case Study of Favipiravir	18

Pharmacokinetics, Pharmacodynamics, and Therapeutic Drug Monitoring of Valganciclovir and Ganciclovir in Transplantation	18
Considerations for Human ADME Strategy and Design Paradigm Shift(s) – An Industry White Paper	18
Discovery of Nonracemic Amisulpride to Maximize Benefit/Risk of 5‐HT7 and D2 Receptor Antagonism for the Treatment of Mood Disorders	18
Evaluation of Meropenem‐Ciprofloxacin Combination Dosage Regimens for the Pharmacokinetics of Critically Ill Patients With Augmented Renal Clearance	18
Translational Approaches for Brain Delivery of Biologics via Cerebrospinal Fluid	17
Toward Project Optimus for Oncology Precision Medicine: Multi‐Dimensional Dose Optimization Enabled by Quantitative Clinical Pharmacology	17
In Vivo Cellular Expansion of Lisocabtagene Maraleucel and Association With Efficacy and Safety in Relapsed/Refractory Large B‐Cell Lymphoma	17
Quantitative Proteomic Map of Enzymes and Transporters in the Human Kidney: Stepping Closer to Mechanistic Kidney Models to Define Local Kinetics	17
Clinical Translation of Targeted Protein Degraders	17
Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator	17
The Polymorphic Nuclear Factor NFIB Regulates Hepatic CYP2D6 Expression and Influences Risperidone Metabolism in Psychiatric Patients	17
Characterization of CYP2D6 Pharmacogenetic Variation in Sub‐Saharan African Populations	17
Physiologically Based Pharmacokinetic Modelling to Investigate the Impact of the Cytokine Storm on CYP3A Drug Pharmacokinetics in COVID‐19 Patients	17
Clinical Characteristics and Outcome of Drug‐Induced Liver Injury in the Older Patients: From the Young‐Old to the Oldest‐Old	17
Metabolism and Excretion of Nirmatrelvir in Humans Using Quantitative Fluorine Nuclear Magnetic Resonance Spectroscopy: A Novel Approach for Accelerating Drug Development	17
TPMT and NUDT15 Variants Predict Discontinuation of Azathioprine for Myelotoxicity in Patients with Inflammatory Disease: Real‐World Clinical Results	17
Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program	17
Effects of Protein and Calorie Restriction on the Metabolism and Toxicity Profile of Irinotecan in Cancer Patients	17
Current Practices, Gap Analysis, and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective	17
Emulating Control Arms for Cancer Clinical Trials Using External Cohorts Created From Electronic Health Record‐Derived Real‐World Data	17
Exposure–Efficacy Analysis of Asciminib in Philadelphia Chromosome–Positive Chronic Myeloid Leukemia in Chronic Phase	17
The Role of Pharmacogenetics in Smoking	16
Characterizing Effects of Antidiabetic Drugs on Heart Rate, Systolic and Diastolic Blood Pressure	16
A Quantitative Modeling and Simulation Framework to Support Candidate and Dose Selection of Anti‐SARS‐CoV‐2 Monoclonal Antibodies to Advance Bamlanivimab Into a First‐in‐Human Clinical Trial	16
Evaluation of Cytochrome P450‐Mediated Cannabinoid‐Drug Interactions in Healthy Adult Participants	16
Moving From Point‐Based Analysis to Systems‐Based Modeling: Integration of Knowledge to Address Antimicrobial Resistance Against MDR Bacteria	16
Effect of Hepatic Impairment on OATP1B Activity: Quantitative Pharmacokinetic Analysis of Endogenous Biomarker and Substrate Drugs	16
Lymphocyte Profile and Immune Checkpoint Expression in Drug‐Induced Liver Injury: An Immunophenotyping Study	16
Effect of SLCO1B1 T521C on Statin‐Related Myotoxicity With Use of Lovastatin and Atorvastatin	16
Drug‐Drug‐Gene Interactions: A Call for Clinical Consideration	16
DrugWAS: Drug‐wide Association Studies for COVID‐19 Drug Repurposing	15
An Open Label, Adaptive, Phase 1 Trial of High‐Dose Oral Nitazoxanide in Healthy Volunteers: An Antiviral Candidate for SARS‐CoV‐2	15
Real‐world Overall Survival Using Oncology Electronic Health Record Data: Friends of Cancer Research Pilot	15
Physiologically‐Based Pharmacokinetic Modeling‐Guided Dose Management of Oral Anticoagulants when Initiating Nirmatrelvir/Ritonavir (Paxlovid) for COVID‐19 Treatment	15
Physiologically‐Based Pharmacokinetic Modeling to Support the Clinical Management of Drug–Drug Interactions With Bictegravir	15
Prognostic Factors and Treatment‐Effect Modifiers in Spinal Muscular Atrophy	15
Incretin‐Based Drugs and Risk of Intestinal Obstruction Among Patients With Type 2 Diabetes	15
The Evidence REVEAL Study: Exploring the Use of Real‐World Evidence and Complex Clinical Trial Design by the European Pharmaceutical Industry	15
Prevalence of Avoidable and Bias‐Inflicting Methodological Pitfalls in Real‐World Studies of Medication Safety and Effectiveness	15
Current and Next Steps Toward Prediction of Human Dose for Gene Therapy Using Translational Dose‐Response Studies	15
Evaluation of a Pilot Vancomycin Precision Dosing Advisory Service on Target Exposure Attainment Using an Interrupted Time Series Analysis	15
Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction	15
Safety, Tolerability, and Pharmacokinetics of FAAH Inhibitor BIA 10‐2474: A Double‐Blind, Randomized, Placebo‐Controlled Study in Healthy Volunteers	15
Medication Errors During Treatment with New Oral Anticancer Agents: Consequences for Clinical Practice Based on the AMBORA Study	15
Use of Real‐World Data and Physiologically‐Based Pharmacokinetic Modeling to Characterize Enoxaparin Disposition in Children With Obesity	15
Semimechanistic Physiologically‐Based Pharmacokinetic/Pharmacodynamic Model Informing Epcoritamab Dose Selection for Patients With B‐Cell Lymphomas	15
Physiologically‐Based Pharmacokinetic Models as Enablers of Precision Dosing in Drug Development: Pivotal Role of the Human Mass Balance Study	15
Pharmacogenomic‐Guided Therapy in Colorectal Cancer	14
Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World	14
When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?	14
Pharmacogenetics‐Guided Advances in Antipsychotic Treatment	14
When Can We Trust Real‐World Data To Evaluate New Medical Treatments?	14
US Taxpayers Heavily Funded the Discovery of COVID‐19 Vaccines	14
Machine Learning as a Novel Method to Support Therapeutic Drug Management and Precision Dosing	14
Clinical Assessment of the Drug Interaction Potential of the Psychotropic Natural Product Kratom	14
Development of a Generic Physiologically‐Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk	14
Presence of Five Chemotherapeutic Drugs in Breast Milk as a Guide for the Safe Use of Chemotherapy During Breastfeeding: Results From a Case Series	13
Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)	13
Sulfonylureas and the Risk of Ventricular Arrhythmias Among People with Type 2 Diabetes: A Systematic Review of Observational Studies	13
Genetic Variation in Sodium‐glucose Cotransporter 2 and Heart Failure	13
Impact of the ABCD‐GENE Score on Clopidogrel Clinical Effectiveness after PCI: A Multi‐Site, Real‐World Investigation	13
Model‐Informed Drug Development: Connecting the Dots With a Totality of Evidence Mindset to Advance Therapeutics	13
Pharmacogenomic Clinical Decision Support: A Scoping Review	13
Cross‐Ancestry Genome‐Wide Association Study Defines the Extended CYP2D6 Locus as the Principal Genetic Determinant of Endoxifen Plasma Concentrations	13
Understanding the Blood‐Brain Barrier and Beyond: Challenges and Opportunities for Novel CNS Therapeutics	13
SLCO1B15* Allele Is Associated With Atorvastatin Discontinuation and Adverse Muscle Symptoms in the Context of Routine Care	13
Metamizole is a Moderate Cytochrome P450 Inducer Via the Constitutive Androstane Receptor and a Weak Inhibitor of CYP1A2	13
Effect of Chronic Kidney Disease on the Renal Secretion via Organic Anion Transporters 1/3: Implications for Physiologically‐Based Pharmacokinetic Modeling and Dose Adjustment	13
Population Pharmacokinetic Modeling and Probability of Pharmacodynamic Target Attainment for Ceftazidime‐Avibactam in Pediatric Patients Aged 3 Months and Older	13
Utility of Normalized TdP Score System in Drug Proarrhythmic Potential Assessment: A Blinded in vitro Study of CiPA Drugs	13
Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan	13
3D Spheroid Primary Human Hepatocytes for Prediction of Cytochrome P450 and Drug Transporter Induction	13
Acute and Chronic Effects of Rifampin on Letermovir Suggest Transporter Inhibition and Induction Contribute to Letermovir Pharmacokinetics	13
Pharmacology of HIV Cure: Site of Action	13
Reimagining the Framework Supporting the Static Analysis of Transporter Drug Interaction Risk; Integrated Use of Biomarkers to Generate Pan‐Transporter Inhibition Signatures	13
Assessment of the Delay in Novel Anticancer Drugs between China and the United States: A Comparative Study of Drugs Approved between 2010 and 2021	13
Real‐World Comparative Effectiveness and Safety of Non‐Vitamin K Antagonist Oral Anticoagulants vs. Warfarin in a Developing Country	13
Diversity and Inclusion in Drug Development: Rethinking Intrinsic and Extrinsic Factors with Patient Centricity	13
COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union	13
Leveraging Human Plasma‐Derived Small Extracellular Vesicles as Liquid Biopsy to Study the Induction of Cytochrome P450 3A4 by Modafinil	12
The Central Role of pH in the Clinical Pharmacology of Nicotine: Implications for Abuse Liability, Cigarette Harm Reduction and FDA Regulation	12
Prediction of Busulfan Clearance by Predose Plasma Metabolomic Profiling	12
Metformin Stimulates Intestinal Glycolysis and Lactate Release: A single‐Dose Study of Metformin in Patients With Intrahepatic Portosystemic Stent	12
Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective	12
Toward Bridging Unmet Medical Need in Early Alzheimer’s Disease: An Evaluation of Beta‐Amyloid (Aβ) Plaque Burden as a Potential Drug Development Tool	12
Clinical Pharmacology Perspectives for Adoptive Cell Therapies in Oncology	12
Estimands and Complex Innovative Designs	12
Response to the FDA Decision Regarding DPYD Testing Prior to Fluoropyrimidine Chemotherapy	12
Development and Bioequivalence of 3D‐Printed Medication at the Point‐of‐Care: Bridging the Gap Toward Personalized Medicine	12
Effect of a Ketohexokinase Inhibitor (PF‐06835919) on In Vivo OATP1B Activity: Integrative Risk Assessment Using Endogenous Biomarker and a Probe Drug	12
Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed	12
Serotonin‐Affecting Antidepressant Use in Relation to Platelet Reactivity	12
Renal Transporter‐Mediated Drug‐Biomarker Interactions of the Endogenous Substrates Creatinine and N¹‐Methylnicotinamide: A PBPK Modeling Approach	12
From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology Modeling in Cancer Immunotherapy	12
Development of Therapeutic Proteins for a New Subcutaneous Route of Administration After the Establishment of Intravenous Dosages: A Systematic Review	11