OOIR: Observatory of International Research

Papers

(The TQCC of Clinical Pharmacology & Therapeutics is 9. 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 2020-04-01 to 2024-04-01.)

Article	Citations
An Evidence‐Based Framework for Evaluating Pharmacogenomics Knowledge for Personalized Medicine	311
Favipiravir: Pharmacokinetics and Concerns About Clinical Trials for 2019‐nCoV Infection	268
Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2D6, OPRM1, and COMT Genotypes and Select Opioid Therapy	204
Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2C9 and Nonsteroidal Anti‐Inflammatory Drugs	191
Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 Genotype and Clopidogrel Therapy: 2022 Update	165
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and Proton Pump Inhibitor Dosing	149
The Approved Dose of Ivermectin Alone is not the Ideal Dose for the Treatment of COVID‐19	137
From Therapeutic Drug Monitoring to Model‐Informed Precision Dosing for Antibiotics	132
Recommendations for the Management of Drug–Drug Interactions Between the COVID‐19 Antiviral Nirmatrelvir/Ritonavir (Paxlovid) and Comedications	121
The Clinical Pharmacogenetics Implementation Consortium Guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and Statin‐Associated Musculoskeletal Symptoms	121
Clinical Pharmacology Perspectives on the Antiviral Activity of Azithromycin and Use in COVID‐19	116
Prioritization of Anti‐SARS‐Cov‐2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics	110
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C9 and HLA‐B Genotypes and Phenytoin Dosing: 2020 Update	99
Risks of ACE Inhibitor and ARB Usage in COVID‐19: Evaluating the Evidence	97
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth	93
Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value	85
Single‐Dose Pharmacokinetics and Pharmacodynamics of Transthyretin Targeting N‐acetylgalactosamine–Small Interfering Ribonucleic Acid Conjugate, Vutrisiran, in Healthy Subjects	85
The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review	84
From Real‐World Patient Data to Individualized Treatment Effects Using Machine Learning: Current and Future Methods to Address Underlying Challenges	83
Optimizing Hydroxychloroquine Dosing for Patients With COVID‐19: An Integrative Modeling Approach for Effective Drug Repurposing	79
Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID‐19 Trial of Nirmatrelvir	74
Incidence of Adverse Drug Reactions in COVID‐19 Patients in China: An Active Monitoring Study by Hospital Pharmacovigilance System	74
Pharmacogenetics at Scale: An Analysis of the UK Biobank	72
PharmVar GeneFocus: CYP2C19	70
Mechanistic Modeling of SARS‐CoV‐2 and Other Infectious Diseases and the Effects of Therapeutics	64

Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials	62
Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective	61
The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications	61
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?	59
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A Genotypes and Serotonin Reuptake Inhibitor Antide	58
Pharmacogene Variation Consortium: A Global Resource and Repository for Pharmacogene Variation	58
Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Study in Healthy Subjects	56
Mechanisms and Rationale for Targeted Therapies in Refractory and Unexplained Chronic Cough	55
Association Between FIASMAs and Reduced Risk of Intubation or Death in Individuals Hospitalized for Severe COVID‐19: An Observational Multicenter Study	53
Liquid Biopsy Enables Quantification of the Abundance and Interindividual Variability of Hepatic Enzymes and Transporters	53
Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database	50
The Treatment of Tuberculosis	49
Cannabidiol and Abnormal Liver Chemistries in Healthy Adults: Results of a Phase I Clinical Trial	49
Artificial Intelligence and Mechanistic Modeling for Clinical Decision Making in Oncology	49
Characterizing Exposure–Response Relationship for Therapeutic Monoclonal Antibodies in Immuno‐Oncology and Beyond: Challenges, Perspectives, and Prospects	47
Clinical Pharmacogenetics Implementation Consortium Guideline for the Use of Aminoglycosides Based on MT‐RNR1 Genotype	47
Model‐Based Cellular Kinetic Analysis of Chimeric Antigen Receptor‐T Cells in Humans	47
Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates)	46
Response to Inhibition of Receptor‐Interacting Protein Kinase 1 (RIPK1) in Active Plaque Psoriasis: A Randomized Placebo‐Controlled Study	45
Finding the Dose for Hydroxychloroquine Prophylaxis for COVID‐19: The Desperate Search for Effectiveness	44
Tacrolimus Exposure Prediction Using Machine Learning	44
Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective	43
Impact of Acute Inflammation on Cytochromes P450 Activity Assessed by the Geneva Cocktail	42
Role of Drugs Used for Chronic Disease Management on Susceptibility and Severity of COVID‐19: A Large Case‐Control Study	42
A Model Averaging/Selection Approach Improves the Predictive Performance of Model‐Informed Precision Dosing: Vancomycin as a Case Study	42
Model‐Informed Drug Development for Anti‐Infectives: State of the Art and Future	41
Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe	40
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	40
Use of Real‐World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design	40
Pharmacokinetics of Oral Nirmatrelvir/Ritonavir, a Protease Inhibitor for Treatment of COVID‐19, in Subjects With Renal Impairment	39
COVIDOSE: A Phase II Clinical Trial of Low‐Dose Tocilizumab in the Treatment of Noncritical COVID‐19 Pneumonia	39
Quantitative Systems Pharmacology Approaches for Immuno‐Oncology: Adding Virtual Patients to the Development Paradigm	39
Inflammation, Lifestyle Factors, and the Microbiome‐Gut‐Brain Axis: Relevance to Depression and Antidepressant Action	39
Neuronavigation‐Guided rTMS for the Treatment of Depressive Patients With Suicidal Ideation: A Double‐Blind, Randomized, Sham‐Controlled Trial	39
How to Integrate CYP2D6 Phenoconversion Into Clinical Pharmacogenetics: A Tutorial	39
Real‐World Infliximab Pharmacokinetic Study Informs an Electronic Health Record‐Embedded Dashboard to Guide Precision Dosing in Children with Crohn’s Disease	38
Developing Drugs for Tissue‐Agnostic Indications: A Paradigm Shift in Leveraging Cancer Biology for Precision Medicine	38
Countermeasures for Preventing and Treating Opioid Overdose	37
A New Era in Pharmacovigilance: Toward Real‐World Data and Digital Monitoring	37
Association Between Use of Pharmacokinetic‐Interacting Drugs and Effectiveness and Safety of Direct Acting Oral Anticoagulants: Nested Case‐Control Study	37
Treatment of Fabry's Disease With Migalastat: Outcome From a Prospective Observational Multicenter Study (FAMOUS)	37
Impact of SARS‐CoV‐2 Infection (COVID‐19) on Cytochromes P450 Activity Assessed by the Geneva Cocktail	36
Intestinal P‐gp and Putative Hepatic OATP1B Induction: International Transporter Consortium Perspective on Drug Development Implications	36
The Drug Shortage Era: A Scoping Review of the Literature 2001–2019	35
Perspectives on Model‐Informed Precision Dosing in the Digital Health Era: Challenges, Opportunities, and Recommendations	35
Individualized Dosing of Fluoropyrimidine‐Based Chemotherapy to Prevent Severe Fluoropyrimidine‐Related Toxicity: What Are the Options?	35
Opportunity for Genotype‐Guided Prescribing Among Adult Patients in 11 US Health Systems	35
Global Frequencies of Clinically Important HLA Alleles and Their Implications For the Cost‐Effectiveness of Preemptive Pharmacogenetic Testing	34
Genetic Association of Co‐Trimoxazole‐Induced Severe Cutaneous Adverse Reactions Is Phenotype‐Specific: HLA Class I Genotypes and Haplotypes	34
Pharmacogenomic Testing and Depressive Symptom Remission: A Systematic Review and Meta‐Analysis of Prospective, Controlled Clinical Trials	34

A Tutorial for Pharmacogenomics Implementation Through End‐to‐End Clinical Decision Support Based on Ten Years of Experience from PREDICT	34
PharmVar GeneFocus: CYP2C9	34
Cost Effectiveness of Pharmacogenetic Testing for Drugs with Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines: A Systematic Review	34
Abundance of P‐Glycoprotein and Other Drug Transporters at the Human Blood‐Brain Barrier in Alzheimer’s Disease: A Quantitative Targeted Proteomic Study	33
PharmVar GeneFocus: CYP2B6	33
Dose Rationale for Favipiravir Use in Patients Infected With SARS‐CoV‐2	32
MTXPK.org: A Clinical Decision Support Tool Evaluating High‐Dose Methotrexate Pharmacokinetics to Inform Post‐Infusion Care and Use of Glucarpidase	32
Dihydropyrimidine Dehydrogenase Phenotyping Using Pretreatment Uracil: A Note of Caution Based on a Large Prospective Clinical Study	32
Genomewide Association Studies in Pharmacogenomics	32
Drug Dosing Recommendations for All Patients: A Roadmap for Change	32
Genomewide Association Study of Platelet Reactivity and Cardiovascular Response in Patients Treated With Clopidogrel: A Study by the International Clopidogrel Pharmacogenomics Consortium	32
A Microdose Cocktail to Evaluate Drug Interactions in Patients with Renal Impairment	31
Interventional Pharmacoeconomics: A Novel Mechanism for Unlocking Value	31
Different Strategies to Execute Multi‐Database Studies for Medicines Surveillance in Real‐World Setting: A Reflection on the European Model	31
Moving Pharmacogenetics Into Practice: It’s All About the Evidence!	31
Mechanistic Quantitative Pharmacology Strategies for the Early Clinical Development of Bispecific Antibodies in Oncology	30
Exposure–Response Analyses of Anaplastic Lymphoma Kinase Inhibitors Crizotinib and Alectinib in Non‐Small Cell Lung Cancer Patients	30
Immunopharmacogenomics: Mechanisms of HLA‐Associated Drug Reactions	30
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding	30
Genetic Risk Factors in Drug‐Induced Liver Injury Due to Isoniazid‐Containing Antituberculosis Drug Regimens	30
Identification of Glycochenodeoxycholate 3‐O‐Glucuronide and Glycodeoxycholate 3‐O‐Glucuronide as Highly Sensitive and Specific OATP1B1 Biomarkers	30
Clinically Relevant Cytochrome P450 3A4 Induction Mechanisms and Drug Screening in Three‐Dimensional Spheroid Cultures of Primary Human Hepatocytes	30
StellarPGx: A Nextflow Pipeline for Calling Star Alleles in Cytochrome P450 Genes	29
Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID‐19 Infection	28
The Systems Biology of Drug Metabolizing Enzymes and Transporters: Relevance to Quantitative Systems Pharmacology	28
A Genome‐wide Association Study of Circulating Levels of Atorvastatin and Its Major Metabolites	28
A Novel CYP2C‐Haplotype Associated With Ultrarapid Metabolism of Escitalopram	28
Fenofibrate Improves Liver Function and Reduces the Toxicity of the Bile Acid Pool in Patients With Primary Biliary Cholangitis and Primary Sclerosing Cholangitis Who Are Partial Responders to Ursodio	27
Benefit‐Risk Assessment of Off‐Label Drug Use in Children: The Bravo Framework	27
Impact of Disease on Plasma and Lung Exposure of Chloroquine, Hydroxychloroquine and Azithromycin: Application of PBPK Modeling	27
Identification of Appropriate Endogenous Biomarker for Risk Assessment of Multidrug and Toxin Extrusion Protein‐Mediated Drug‐Drug Interactions in Healthy Volunteers	27
IL‐17 Inhibitors and Inflammatory Bowel Diseases: A Postmarketing Study in Vigibase	27
Chloroquine Dosing Recommendations for Pediatric COVID‐19 Supported by Modeling and Simulation	26
Regulation of Drug Transport Proteins—From Mechanisms to Clinical Impact: A White Paper on Behalf of the International Transporter Consortium	26
Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness	26
Relationship Between Progression‐Free Survival, Objective Response Rate, and Overall Survival in Clinical Trials of PD‐1/PD‐L1 Immune Checkpoint Blockade: A Meta‐Analysis	26
Does In Vitro Potency Predict Clinically Efficacious Concentrations?	26
Clinical and Molecular Perspectives on Inflammation‐Mediated Regulation of Drug Metabolism and Transport	26
Pharmacokinetics and Pharmacodynamics of Lysergic Acid Diethylamide Microdoses in Healthy Participants	26
Optimizing Pharmacology Studies in Pregnant and Lactating Women Using Lessons From HIV: A Consensus Statement	26
Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012–2018	26
Mycophenolic Acid Exposure Prediction Using Machine Learning	26
Physiologically‐Based Pharmacokinetic Modeling Characterizes the CYP3A‐Mediated Drug‐Drug Interaction Between Fluconazole and Sildenafil in Infants	26
Artificial Intelligence for Unstructured Healthcare Data: Application to Coding of Patient Reporting of Adverse Drug Reactions	25
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?	25
Real‐World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID‐19	25
Transporters in Drug Development: International Transporter Consortium Update on Emerging Transporters of Clinical Importance	25
Features of Inflammatory Heart Reactions Following mRNA COVID‐19 Vaccination at a Global Level	25
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective	25
Pharmacogenetics of Bleeding and Thromboembolic Events in Direct Oral Anticoagulant Users	25
The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework	25
Genomewide Meta‐Analysis Validates a Role for S1PR1 in Microtubule Targeting Agent‐Induced Sensory Peripheral Neuropathy	24
Avoiding Tacrolimus Underexposure and Overexposure with a Dosing Algorithm for Renal Transplant Recipients: A Single Arm Prospective Intervention Trial	24
Population Pharmacokinetics of Trastuzumab Deruxtecan in Patients With HER2‐Positive Breast Cancer and Other Solid Tumors	24
How to Transition from Single‐Gene Pharmacogenetic Testing to Preemptive Panel‐Based Testing: A Tutorial	24
Systematic Review and Patient‐Level Meta‐Analysis of SARS‐CoV‐2 Viral Dynamics to Model Response to Antiviral Therapies	24
First‐in‐Human Study of Bamlanivimab in a Randomized Trial of Hospitalized Patients With COVID‐19	24
Impact of the CYP2C1917* Allele on Outcomes in Patients Receiving Genotype‐Guided Antiplatelet Therapy After Percutaneous Coronary Intervention	24
Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019	24
Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID‐19 Infection	24
Drug‐Drug Interactions Involving Renal OCT2/MATE Transporters: Clinical Risk Assessment May Require Endogenous Biomarker‐Informed Approach	23
Physiologically Based Precision Dosing Approach for Drug‐Drug‐Gene Interactions: A Simvastatin Network Analysis	23
Pharmacogenetic Predictors of Cannabidiol Response and Tolerability in Treatment‐Resistant Epilepsy	23
Sex and Gender Differences in Clinical Pharmacology: Implications for Transgender Medicine	23
Pharmacogenomic Clinical Decision Support: A Review, How‐to Guide, and Future Vision	23
Biomarker‐Guided Individualization of Antibiotic Therapy	23
Off‐Label Therapies for COVID‐19—Are We All In This Together?	23
Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan	22
Sex‐Specific Classification of Drug‐Induced Torsade de Pointes Susceptibility Using Cardiac Simulations and Machine Learning	22
Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making	22
Rational Clinical Dose Selection of Adeno‐Associated Virus‐Mediated Gene Therapy Based on Allometric Principles	22
Continuous Learning in Model‐Informed Precision Dosing: A Case Study in Pediatric Dosing of Vancomycin	22
Evaluation of the CYP2D6 Haplotype Activity Scores Based on Metabolic Ratios of 4,700 Patients Treated With Three Different CYP2D6 Substrates	22
QT Interval Prolongation Under Hydroxychloroquine/Azithromycin Association for Inpatients With SARS‐CoV‐2 Lower Respiratory Tract Infection	22
Liquid Biopsy for Patient Characterization in Cardiovascular Disease: Verification against Markers of Cytochrome P450 and P‐Glycoprotein Activities	22
Collaborative Platform Trials to Fight COVID‐19: Methodological and Regulatory Considerations for a Better Societal Outcome	22
Propranolol Suppresses the Growth of Colorectal Cancer Through Simultaneously Activating Autologous CD8⁺ T Cells and Inhibiting Tumor AKT/MAPK Pathway	22
Off‐Label, but on‐Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy	21
Tolerance to Opioid‐Induced Respiratory Depression in Chronic High‐Dose Opioid Users: A Model‐Based Comparison With Opioid‐Naïve Individuals	21
Assuring Access to Safe Medicines in Pregnancy and Breastfeeding	21

Clinical Implications of Altered Drug Transporter Abundance/Function and PBPK Modeling in Specific Populations: An ITC Perspective	21
Exposure‐Response Relationships in Patients With HER2‐Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan	21
Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021	21
Quantification of Proteins Involved in Intestinal Epithelial Handling of Xenobiotics	21
MASTER KEY Project: Powering Clinical Development for Rare Cancers Through a Platform Trial	21
Model‐Based Drug–Drug Interaction Extrapolation Strategy From Adults to Children: Risdiplam in Pediatric Patients With Spinal Muscular Atrophy	21
Assessing Transporter‐Mediated Natural Product‐Drug Interactions Via In vitro‐In Vivo Extrapolation: Clinical Evaluation With a Probe Cocktail	21
Real‐World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men	21
Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis	21
Biomarker‐Informed Model‐Based Risk Assessment of Organic Anion Transporting Polypeptide 1B Mediated Drug‐Drug Interactions	21
Perspectives on Virtual (Remote) Clinical Trials as the “New Normal” to Accelerate Drug Development	21
A Systematic Review and Analysis of the Use of Polygenic Scores in Pharmacogenomics	20
Anticoagulant Treatment Regimens in Patients With Covid‐19: A Meta‐Analysis	20
P‐Glycoprotein Inhibition Exacerbates Paclitaxel Neurotoxicity in Neurons and Patients With Cancer	20
Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019	20
Performance of Plasma Coproporphyrin I and III as OATP1B1 Biomarkers in Humans	20
The Friends of Cancer Research Real‐World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies	20
Pharmacokinetics and Drug‐Drug Interactions of Isoniazid and Efavirenz in Pregnant Women Living With HIV in High TB Incidence Settings: Importance of Genotyping	20
Clinical Trials for COVID‐19: Can we Better Use the Short Window of Opportunity?	20
Blockade of Organic Anion Transport in Humans After Treatment With the Drug Probenecid Leads to Major Metabolic Alterations in Plasma and Urine	19
Key Challenges in Providing Effective Antibiotic Therapy for Critically Ill Patients with Bacterial Sepsis and Septic Shock	19
Pharmacokinetics and Pharmacodynamics of Oral Psilocybin Administration in Healthy Participants	19
Model‐Informed Drug Development for Antimicrobials: Translational PK and PK/PD Modeling to Predict an Efficacious Human Dose for Apramycin	19
Translational Pharmacogenomics: Discovery, Evidence Synthesis and Delivery of Race‐Conscious Medicine	19
The Drug Titration Paradox: Correlation of More Drug With Less Effect in Clinical Data	19
Roadmap to 2030 for Drug Evaluation in Older Adults	19
Physiologically‐Based Pharmacokinetic Modeling of Remdesivir and Its Metabolites to Support Dose Selection for the Treatment of Pediatric Patients With COVID‐19	19
An Electronic Health Record Text Mining Tool to Collect Real‐World Drug Treatment Outcomes: A Validation Study in Patients With Metastatic Renal Cell Carcinoma	19
A Useful and Sustainable Role for N‐of‐1 Trials in the Healthcare Ecosystem	19
Leading a Digital Transformation in the Pharmaceutical Industry: Reimagining the Way We Work in Global Drug Development	19
OX40L Inhibition Suppresses KLH‐driven Immune Responses in Healthy Volunteers: A Randomized Controlled Trial Demonstrating Proof‐of‐Pharmacology for KY1005	18
Predicting Inpatient Medication Orders From Electronic Health Record Data	18
Quantification of In Vivo Metabolic Activity of CYP2D6 Genotypes and Alleles Through Population Pharmacokinetic Analysis of Vortioxetine	18
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	18
Model‐Based Quantification of Impact of Genetic Polymorphisms and Co‐Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer	18
Toward Consensus on Correct Interpretation of Protein Binding in Plasma and Other Biological Matrices for COVID‐19 Therapeutic Development	18
Pivotal Role of Translation in Anti‐Infective Development	18
Assessment of Placental Disposition of Infliximab and Etanercept in Women With Autoimmune Diseases and in the Ex Vivo Perfused Placenta	18
PharmVar GeneFocus: SLCO1B1	18
The Lymph Node Reservoir: Physiology, HIV Infection, and Antiretroviral Therapy	18
NT‐proBNP Qualifies as a Surrogate for Clinical End Points in Heart Failure	18
Can In Vitro–In Vivo Extrapolation Be Successful? Recognizing the Incorrect Clearance Assumptions	18
Depletion of LAG‐3⁺ T Cells Translated to Pharmacology and Improvement in Psoriasis Disease Activity: A Phase I Randomized Study of mAb GSK2831781	18
Exome Sequencing Reveals Common and Rare Variants in F5 Associated With ACE Inhibitor and Angiotensin Receptor Blocker–Induced Angioedema	18
Japan’s Drug Regulation During the COVID‐19 Pandemic: Lessons From a Case Study of Favipiravir	18
Ribociclib Drug‐Drug Interactions: Clinical Evaluations and Physiologically‐Based Pharmacokinetic Modeling to Guide Drug Labeling	18
Dihydropyrimidine Dehydrogenase Deficiency and Implementation of UpfrontDPYDGenotyping	17
Successful Prediction of Human Steady‐State Unbound Brain‐to‐Plasma Concentration Ratio of P‐gp Substrates Using the Proteomics‐Informed Relative Expression Factor Approach	17
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	17
The Microbiome and the Gut‐Liver‐Brain Axis for Central Nervous System Clinical Pharmacology: Challenges in Specifying and Integrating In Vitro and In Silico Models	17
Pivotal Dose of Pembrolizumab: A Dose‐Finding Strategy for Immuno‐Oncology	17
Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations	17
A Drug‐Drug Interaction Study Evaluating the Effect of Givosiran, a Small Interfering Ribonucleic Acid, on Cytochrome P450 Activity in the Liver	17
Use of Real‐World Data to Emulate a Clinical Trial and Support Regulatory Decision Making: Assessing the Impact of Temporality, Comparator Choice, and Method of Adjustment	17
New and Emerging Research on Solute Carrier and ATP Binding Cassette Transporters in Drug Discovery and Development: Outlook From the International Transporter Consortium	17
Physiologically‐Based Pharmacokinetic‐Led Guidance for Patients With Cystic Fibrosis Taking Elexacaftor‐Tezacaftor‐Ivacaftor With Nirmatrelvir‐Ritonavir for the Treatment of COVID‐19	17
Physiologically Based Pharmacokinetic Modeling of Central Nervous System Pharmacokinetics of CDK4/6 Inhibitors to Guide Selection of Drug and Dosing Regimen for Brain Cancer Treatment	17
Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting	17
Physiologically‐Based Pharmacokinetic Model of Morphine and Morphine‐3‐Glucuronide in Nonalcoholic Steatohepatitis	17
Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression	17
The Implausibility of Neonatal Opioid Toxicity from Breastfeeding	17
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	17
Management of Osteoarthritis During the COVID‐19 Pandemic	17
Cannabidivarin for HIV‐Associated Neuropathic Pain: A Randomized, Blinded, Controlled Clinical Trial	16
Translational Approaches for Brain Delivery of Biologics via Cerebrospinal Fluid	16
Evaluation of Meropenem‐Ciprofloxacin Combination Dosage Regimens for the Pharmacokinetics of Critically Ill Patients With Augmented Renal Clearance	16
Effect of Cyclosporin A and Impact of Dose Staggering on OATP1B1/1B3 Endogenous Substrates and Drug Probes for Assessing Clinical Drug Interactions	16
Circadian Variation in Efficacy of Medications	16
The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States	16
Maternal Betamethasone for Prevention of Respiratory Distress Syndrome in Neonates: Population Pharmacokinetic and Pharmacodynamic Approach	16
Coprescription of Opioids With Other Medications and Risk of Opioid Overdose	16
The Lymphoid Tissue Pharmacokinetics of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide in HIV‐Infected Persons	16
Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a Randomized Placebo‐Controlled Trial	16
Clinical Characteristics and Outcome of Drug‐Induced Liver Injury in the Older Patients: From the Young‐Old to the Oldest‐Old	16
Pregnane X Receptor Activator Rifampin Increases Blood Pressure and Stimulates Plasma Renin Activity	16
Obesity Alters Endoxifen Plasma Levels in Young Breast Cancer Patients: A Pharmacometric Simulation Approach	16
Local Transdermal Delivery of Telapristone Acetate Through Breast Skin, Compared With Oral Treatment: A Randomized Double‐Blind, Placebo‐Controlled Phase II Trial	16
The Certainty Framework for Assessing Real‐World Data in Studies of Medical Product Safety and Effectiveness	16
Drugs in COVID‐19 Clinical Trials: Predicting Transporter‐Mediated Drug‐Drug Interactions Using In Vitro Assays and Real‐World Data	16
Drug Disposition Protein Quantification in Matched Human Jejunum and Liver From Donors With Obesity	16
Computational Tools to Assess the Functional Consequences of Rare and Noncoding Pharmacogenetic Variability	16
Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator	16
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020	15
Current and Next Steps Toward Prediction of Human Dose for Gene Therapy Using Translational Dose‐Response Studies	15
Response to "Dose Rationale for Favipiravir Use in Patients Infected With SARS‐CoV‐2"	15
The Effects of Weak and Strong CYP3A Induction by Rifampicin on the Pharmacokinetics of Five Progestins and Ethinylestradiol Compared to Midazolam	15
Transferability of Ancestry‐Specific and Cross‐Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations	15
Effectiveness of Intermittent Preventive Treatment With Dihydroartemisinin‐Piperaqunine Against Malaria in Pregnancy in Tanzania: A Randomized Controlled Trial	15
Proteomics‐Informed Prediction of Rosuvastatin Plasma Profiles in Patients With a Wide Range of Body Weight	15
Evaluation of a Pilot Vancomycin Precision Dosing Advisory Service on Target Exposure Attainment Using an Interrupted Time Series Analysis	15
Stroke and Bleeding Risks in Patients with Atrial Fibrillation Treated with Reduced Apixaban Dose: A Real‐Life Study	15
Physiologically Based Pharmacokinetic Modelling to Investigate the Impact of the Cytokine Storm on CYP3A Drug Pharmacokinetics in COVID‐19 Patients	15
Clinical Relevance of Hepatic and Renal P‐gp/BCRP Inhibition of Drugs: An International Transporter Consortium Perspective	15
Metabolism and Excretion of Nirmatrelvir in Humans Using Quantitative Fluorine Nuclear Magnetic Resonance Spectroscopy: A Novel Approach for Accelerating Drug Development	15
Considerations for Human ADME Strategy and Design Paradigm Shift(s) – An Industry White Paper	15