Journal of Clinical Pharmacology

Papers
(The TQCC of Journal of Clinical Pharmacology is 4. 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.)
ArticleCitations
Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical Pharm78
PEG That Reaction: A Case Series of Allergy to Polyethylene Glycol55
MDMA‐Assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder: A Systematic Review With Meta‐Analysis53
Baricitinib: From Rheumatoid Arthritis to COVID‐1941
The Epidemiology of Drug Abuse37
Pharmacology of Drugs Used as Stimulants32
Chimeric Antigen Receptor T Cell Therapies: A Review of Cellular Kinetic‐Pharmacodynamic Modeling Approaches31
Differential Binding of Sarilumab and Tocilizumab to IL‐6Rα and Effects of Receptor Occupancy on Clinical Parameters31
Effects of Hepatic Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites30
Continued Risk of Dietary Supplements Adulterated With Approved and Unapproved Drugs: Assessment of the US Food and Drug Administration's Tainted Supplements Database 2007 Through 202130
Natural History and Real‐World Data in Rare Diseases: Applications, Limitations, and Future Perspectives30
Neurological Immune‐Related Adverse Events After COVID‐19 Vaccination: A Systematic Review27
Applications of Physiologically Based Pharmacokinetic Modeling of Rivaroxaban—Renal and Hepatic Impairment and Drug‐Drug Interaction Potential23
Clinical Outcome Data of First Cohort of Chronic Pain Patients Treated With Cannabis‐Based Sublingual Oils in the United Kingdom: Analysis From the UK Medical Cannabis Registry22
Gabapentinoid Pharmacology in the Context of Emerging Misuse Liability21
Clinical Pharmacology of Electronic Nicotine Delivery Systems (ENDS): Implications for Benefits and Risks in the Promotion of the Combusted Tobacco Endgame21
Antiretrovirals for Prophylaxis Against COVID‐19: A Comprehensive Literature Review20
Pharmacogenomics and Morphine19
A Physiological Approach to Pharmacokinetics in Chronic Kidney Disease19
Fetal Arrhythmia Diagnosis and Pharmacologic Management19
Potential COVID‐19 Therapeutic Agents and Vaccines: An Evidence‐Based Review19
Pharmacokinetic Simulation Analysis of Less Frequent Nivolumab and Pembrolizumab Dosing: Pharmacoeconomic Rationale for Dose Deescalation18
Clinical Pharmacology, Toxicity, and Abuse Potential of Opioids18
Effects of Renal Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites18
Natural and Synthetic Cannabinoids: Pharmacology, Uses, Adverse Drug Events, and Drug Interactions18
Racial and Ethnic Differences in Drug Disposition and Response: Review of New Molecular Entities Approved Between 2014 and 201917
Isoniazid Population Pharmacokinetics and Dose Recommendation for Korean Patients With Tuberculosis Based on Target Attainment Analysis17
Opioid Treatment for Neonatal Opioid Withdrawal Syndrome: Current Challenges and Future Approaches16
Drug Combination Modeling: Methods and Applications in Drug Development16
A Population Pharmacokinetic Model of Vonoprazan: Evaluating the Effects of Race, Disease Status, and Other Covariates on Exposure15
Intrapulmonary Pharmacokinetic Modeling and Simulation of Cefiderocol, a Parenteral Siderophore Cephalosporin, in Patients With Pneumonia and Healthy Subjects15
Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects15
A Retrospective Analysis of Intravenous vs Oral Antibiotic Step‐Down Therapy for the Treatment of Uncomplicated Streptococcal Bloodstream Infections15
Pediatric Drug‐Drug Interaction Evaluation: Drug, Patient Population, and Methodological Considerations14
Amantadine for COVID‐1914
Exposure‐Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients14
Clinical Pharmacology of the Dietary Supplement Kratom (Mitragyna speciosa)14
Using Endogenous Biomarkers to Derisk Assessment of Transporter‐Mediated Drug‐Drug Interactions: A Scientific Perspective14
Pharmacological Predictors of Morbidity and Mortality in COVID‐1914
Drug Disposition in Subjects With Obesity: The Research Work of Darrell R. Abernethy13
Sedative‐Hypnotic Agents That Impact Gamma‐Aminobutyric Acid Receptors: Focus on Flunitrazepam, Gamma‐Hydroxybutyric Acid, Phenibut, and Selank13
Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment13
Therapeutic Application of Corticosteroids in COVID‐19: A Focus on Optimum Dose and Duration of Therapy13
Use of Real‐World Data and Pharmacometric Modeling in Support of Lacosamide Dosing in Pediatric Patients Under 4 Years of Age13
Ribociclib Population Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Analysis of Neutrophils in Cancer Patients13
Influence of Prednisone on Inflammatory Biomarkers in Community‐Acquired Pneumonia: Secondary Analysis of a Randomized Trial13
Local Investigators Significantly Overestimate Overall Response Rates Compared to Blinded Independent Central Reviews in Phase 2 Oncology Trials12
Pharmacokinetic and Pharmacodynamic Modeling of Tezepelumab to Guide Phase 3 Dose Selection for Patients With Severe Asthma12
Predictive Performance of Physiology‐Based Pharmacokinetic Dose Estimates for Pediatric Trials: Evaluation With 10 Bayer Small‐Molecule Compounds in Children12
Factors Influencing Change in Serum Uric Acid After Administration of the Sodium‐Glucose Cotransporter 2 Inhibitor Luseogliflozin in Patients With Type 2 Diabetes Mellitus12
Physiologically Based Pharmacokinetic Modeling of Metformin in Children and Adolescents With Obesity12
Population Pharmacokinetics of Viloxazine Extended‐Release Capsules in Pediatric Subjects With Attention Deficit/Hyperactivity Disorder12
Utility of Quantitative Proteomics for Enhancing the Predictive Ability of Physiologically Based Pharmacokinetic Models Across Disease States12
Parametric and Nonparametric Methods in Population Pharmacokinetics: Experts’ Discussion on Use, Strengths, and Limitations12
Optimal Dosing of Meropenem in a Small Cohort of Critically Ill Children Receiving Continuous Renal Replacement Therapy12
Drug‐Drug Interaction Studies With Oral Contraceptives: Pharmacokinetic/Pharmacodynamic and Study Design Considerations12
Caplacizumab Model‐Based Dosing Recommendations in Pediatric Patients With Acquired Thrombotic Thrombocytopenic Purpura11
Usage of In Vitro Metabolism Data for Drug‐Drug Interaction in Physiologically Based Pharmacokinetic Analysis Submissions to the US Food and Drug Administration11
Postmenopausal Hormone Therapy—Local and Systemic: A Pharmacologic Perspective11
Evaluation of Drug‐Drug Interactions of Ensitrelvir, a SARS‐CoV‐2 3CL Protease Inhibitor, With Transporter Substrates Based on In Vitro and Clinical Studies11
Clinical Pharmacology Considerations on Recombinant Adeno‐Associated Virus–Based Gene Therapy11
Predicting Human Fetal Drug Exposure Through Maternal‐Fetal PBPK Modeling and In Vitro or Ex Vivo Studies11
QT Prolongation Risk Assessment in Oncology: Lessons Learned From Small‐Molecule New Drug Applications Approved During 2011‐201911
Can PBPK Modeling Streamline Food Effect Assessments?11
Further Evaluation of Coproporphyrins as Clinical Endogenous Markers for OATP1B11
The Interplay Between the Immune System, the Renin‐Angiotensin‐Aldosterone System (RAAS), and RAAS Inhibitors May Modulate the Outcome of COVID‐19: A Systematic Review11
Use of Propensity Scoring and Its Application to Real‐World Data: Advantages, Disadvantages, and Methodological Objectives Explained to Researchers Without Using Mathematical Equations11
Model‐Informed Dose Optimization in Pregnancy11
Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases10
Direct Oral Anticoagulants: An Updated Systematic Review of Their Clinical Pharmacology and Clinical Effectiveness and Safety in Patients With Nonvalvular Atrial Fibrillation10
Effect of Body Fat on Population Pharmacokinetics of High‐Dose Methotrexate in Pediatric Patients With Acute Lymphoblastic Leukemia10
Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Temsavir, the Active Moiety of Fostemsavir10
Application of Physiologically Based Pharmacokinetic‐Pharmacodynamic Modeling in Preterm Neonates to Guide Gentamicin Dosing Decisions and Predict Antibacterial Effect10
Update on Cilostazol: A Critical Review of Its Antithrombotic and Cardiovascular Actions and Its Clinical Applications10
Dose Optimization in Kidney Disease: Opportunities for PBPK Modeling and Simulation10
Factors Affecting Contraception Access and Use in Patients With Opioid Use Disorder10
Population Pharmacokinetics of Ipatasertib and Its Metabolite in Cancer Patients10
Physiologic Changes During Pregnancy and Impact on Small‐Molecule Drugs, Biologic (Monoclonal Antibody) Disposition, and Response10
Pediatric Dose Selection for Therapeutic Proteins10
Evaluation of Lorlatinib Cerebrospinal Fluid Concentrations in Relation to Target Concentrations for Anaplastic Lymphoma Kinase (ALK) Inhibition10
The Pharmacology, Efficacy, and Safety of Rivaroxaban in Renally Impaired Patient Populations10
Off‐Label Use of Hydroxychloroquine in COVID‐19: Analysis of Reports of Suspected Adverse Reactions From the Italian National Network of Pharmacovigilance10
Physiologically Based Pharmacokinetic Modeling for Selumetinib to Evaluate Drug‐Drug Interactions and Pediatric Dose Regimens10
Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model‐Informed Dose Selection for Pediatric Development9
Inclisiran: A Novel Small Interfering RNA Drug for Low‐Density Lipoprotein Reduction9
Ketamine for Refractory Chronic Migraine: An Observational Pilot Study and Metabolite Analysis9
Efficacy and Safety of Adjunctive Serotonin‐Dopamine Activity Modulators in Major Depression: A Meta‐Analysis of Randomized Controlled Trials9
Vedolizumab Immunogenicity With Long‐Term or Interrupted Treatment of Patients With Inflammatory Bowel Disease9
Considerations for Drug Dosing in Premature Infants9
A Population Pharmacokinetic Meta‐Analysis of Veliparib, a PARP Inhibitor, Across Phase 1/2/3 Trials in Cancer Patients9
Physiologically Based Pharmacokinetic Modeling and Allometric Scaling in Pediatric Drug Development: Where Do We Draw the Line?9
Corticosteroids in COVID‐19: We Should Be Mindful of Their Acute Toxicities8
Fever Associated With Dexmedetomidine in Adult Acute Care Patients: A Systematic Review of the Literature8
Model‐Informed Drug Development in Pediatric Dose Selection8
Effectiveness and Safety of Histamine H2 Receptor Antagonists: An Umbrella Review of Meta‐Analyses8
Maternal Exposure and Neonatal Effects of Drugs of Abuse8
Influence of Renal Function on Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose of Romosozumab8
Lithium Pharmacokinetics in the Perinatal Patient With Bipolar Disorder8
A Target‐Mediated Drug Disposition Model to Explain Nonlinear Pharmacokinetics of the 11β‐Hydroxysteroid Dehydrogenase Type 1 Inhibitor SPI‐62 in Healthy Adults8
Population Pharmacokinetics of Olanzapine and Samidorphan When Administered in Combination in Healthy Subjects and Patients With Schizophrenia8
Physiologically Based Pharmacokinetic Model‐Informed Drug Development for Polatuzumab Vedotin: Label for Drug‐Drug Interactions Without Dedicated Clinical Trials8
Prostatic Pharmacokinetic/Pharmacodynamic Evaluation of Ampicillin‐Sulbactam for Bacterial Prostatitis and Preoperative Prophylaxis8
Drug–Drug Interactions in People Living With HIV at Risk of Hepatic and Renal Impairment: Current Status and Future Perspectives8
Heterogeneity in the Identification of Potential Drug‐Drug Interactions in the Intensive Care Unit: A Systematic Review, Critical Appraisal, and Reporting Recommendations8
A Model‐Based Framework to Inform the Dose Selection and Study Design of Emicizumab for Pediatric Patients With Hemophilia A8
Impact of Obesity on Brexpiprazole Pharmacokinetics: Proposal for Improved Initiation of Treatment8
Population Pharmacokinetic Modeling and Simulations of Imipenem in Burn Patients With and Without Continuous Venovenous Hemofiltration in the Military Health System8
Endocrine Adverse Events Caused by Different Types and Different Doses of Immune Checkpoint Inhibitors in the Treatment of Solid Tumors: A Meta‐Analysis and Systematic Review8
Personalized Dosing of Infliximab in Patients With Inflammatory Bowel Disease Using a Bayesian Approach: A Next Step in Therapeutic Drug Monitoring8
Pharmacokinetic/Pharmacodynamic Parameters of Linezolid in the Epithelial Lining Fluid of Patients With Sepsis8
Exposure‐Response Analyses for Upadacitinib Efficacy in Subjects With Atopic Dermatitis—Analyses of Phase 2b Study to Support Selection of Phase 3 Doses7
Meta‐Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure7
Buprenorphine Continuation During Critical Illness Associated With Decreased Inpatient Opioid Use in Individuals Maintained on Buprenorphine for Opioid Use Disorder in a Retrospective Study7
Antibody‐Mediated Rejection in Adult Liver Transplant Recipients: A Case Series and Literature Review7
The Use of Pregnancy Physiologically Based Pharmacokinetic Modeling for Renally Cleared Drugs7
Brexpiprazole Pharmacokinetics in CYP2D6 Poor Metabolizers: Using Physiologically Based Pharmacokinetic Modeling to Optimize Time to Effective Concentrations7
Population Pharmacokinetics and Exposure‐Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light‐Chain Amyloidosis7
Pharmacokinetics of Ribociclib in Subjects With Hepatic Impairment7
Risk of SARS‐CoV‐2 Infection and COVID‐19 Severity Associated With Exposure to Nonsteroidal Anti‐Inflammatory Drugs: Systematic Review and Meta‐Analysis7
Pharmacokinetic Evaluation of Blonanserin Transdermal Patch: Population Analysis and Simulation of Plasma Concentration and Dopamine D2 Receptor Occupancy in Clinical Settings7
Drug‐Drug Interactions of Artemisinin‐Based Combination Therapies in Malaria Treatment: A Narrative Review of the Literature7
Application of Microdosed Intravenous Omeprazole to Determine Hepatic CYP2C19 Activity7
Prediction of Fracture Risk From Early‐Stage Bone Markers in Patients With Osteoporosis Treated With Once‐Yearly Administered Zoledronic Acid7
Pharmacokinetics and Concentration‐Response of Dupilumab in Patients With Seasonal Allergic Rhinitis7
Impact of Physiologically Based Pharmacokinetics, Population Pharmacokinetics and Pharmacokinetics/Pharmacodynamics in the Development of Antibody‐Drug Conjugates7
Assessment of Transporter‐Mediated Drug Interactions for Enasidenib Based on a Cocktail Study in Patients With Relapse or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome7
Dose‐Related Adverse Drug Events in Neonates: Recognition and Assessment7
The Nocebo Response in Pharmacologic Treatments of Primary Headache: A Systematic Review and Meta‐Analysis7
Physiologically Based Pharmacokinetic Modeling to Assess the Impact of CYP2D6‐Mediated Drug‐Drug Interactions on Tramadol and O‐Desmethyltramadol Exposures via Allosteric and Competitive Inhibition7
Biperiden Challenge Model in Healthy Elderly as Proof‐of‐Pharmacology Tool: A Randomized, Placebo‐Controlled Trial7
Informing Development of Bispecific Antibodies Using Physiologically Based Pharmacokinetic‐Pharmacodynamic Models: Current Capabilities and Future Opportunities7
Treatment With Tocilizumab for Patients With COVID‐19 Infections: A Case‐Series Study7
Pain Management Considerations in Patients With Opioid Use Disorder Requiring Critical Care7
Drug Interactions With a Short Course of Nirmatrelvir and Ritonavir: Prescribers and Patients Beware6
Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus6
Nonlinear Population Pharmacokinetics of Anifrolumab in Healthy Volunteers and Patients With Systemic Lupus Erythematosus6
Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study6
Impact of Pregnancy and Vitamin A Supplementation on CYP2D6 Activity6
Use of Physiologically Based Pharmacokinetic Modeling to Evaluate the Impact of Chronic Kidney Disease on CYP3A4‐Mediated Metabolism of Saxagliptin6
The Current Landscape of Novel Formulations and the Role of Mathematical Modeling in Their Development6
P‐Glycoprotein and Organic Anion Transporter Polypeptide 1B/Breast Cancer Resistance Protein Drug Transporter Activity in Pregnant Women Living With HIV6
The European Medicines Agency Experience With Pediatric Dose Selection6
Population Pharmacokinetics and Exposure‐Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies6
Evaluation of the Impact of Ritlecitinib on Organic Cation Transporters Using Sumatriptan and Biomarkers as Probes6
Outcomes Associated With 4‐Factor Prothrombin Complex Concentrate Administration to Reverse Oral Factor Xa Inhibitors in Bleeding Patients6
Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder6
Pharmacokinetics of Asfotase Alfa in Adult Patients With Pediatric‐Onset Hypophosphatasia6
The New S7B/E14 Question and Answer Draft Guidance for Industry: Contents and Commentary6
Population Pharmacokinetic Modeling Combined With Machine Learning Approach Improved Tacrolimus Trough Concentration Prediction in Chinese Adult Liver Transplant Recipients6
Days Needed for the Disappearance of a Cough Due to the Use of an Angiotensin‐Converting Enzyme Inhibitor and Identification of Predisposing Factors Associated With Its Appearance in a Clinical Cohort6
Predictive Value of C‐Reactive Protein and Albumin for Temporal Within‐Individual Pharmacokinetic Variability of Voriconazole in Pediatric Patients Undergoing Hematopoietic Cell Transplantation6
Pharmacogenomics for Drug Dosing in Children: Current Use, Knowledge, and Gaps6
Status Toward the Implementation of Precision Dosing in Children6
Considerations and Challenges in the Remdesivir COVID‐19 Pediatric Development Program6
A Clinical Decision Support Tool to Find the Best Initial Intravenous Cyclosporine Regimen in Pediatric Hematopoietic Stem Cell Transplantation6
Effects of Voriconazole Exposure on the Pharmacokinetics of Tacrolimus in Lung Transplantation Patients, Based on Therapeutic Drug Monitoring Data6
Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐20206
Pharmacologic Similarities and Differences Among Hallucinogens6
Pharmacokinetics and Pharmacodynamics of GalNAc‐Conjugated siRNAs6
Science and Evidence‐Based Review and Approval of COVID‐19 Vaccines: A Statement of Support for the US FDA6
In Silico Re‐Optimization of Atezolizumab Dosing Using Population Pharmacokinetic Simulation and Exposure–Response Simulation6
Effect of Anti‐VEGF Therapy on the Disease Progression of Neovascular Age‐Related Macular Degeneration: A Systematic Review and Model‐Based Meta‐Analysis6
Population Pharmacokinetics and Hemorrhagic Risk Analysis of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation5
Relationship Between Anifrolumab Pharmacokinetics, Pharmacodynamics, and Efficacy in Patients With Moderate to Severe Systemic Lupus Erythematosus5
Regulatory Framework for Drug Development in Rare Diseases5
Clinical Assessment of Fetal Well‐Being and Fetal Safety Indicators5
Bayesian Complex Innovative Trial Designs (CIDs) and Their Use in Drug Development for Rare Disease5
Modeling Complex Pharmacokinetics of Long‐Acting Injectable Products Using Convolution‐Based Models With Nonparametric Input Functions5
A Randomized, Controlled Study to Assess Changes in Biomarkers of Exposures Among Adults Who Smoke That Switch to Oral Nicotine Pouch Products Relative to Continuing Smoking or Stopping All Tobacco Us5
Effect of Renal Impairment on the Pharmacokinetics of Firsocostat, an Acetyl‐Coenzyme A Carboxylase Inhibitor, and Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist5
A Systematic Review of Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder5
Precision Dosing for Tacrolimus Using Genotypes and Clinical Factors in Kidney Transplant Recipients of European Ancestry5
Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015–20205
Potential Drug Interaction Between Favipiravir and Warfarin in Patients With COVID‐19: A Real‐World Observational Study5
Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases5
Disproportionality Analysis on Hypothyroidism With Roxadustat Using the Japanese Adverse Drug Event Database5
Clinical Pharmacology Profile of AMG 119, the First Chimeric Antigen Receptor T (CAR‐T) Cell Therapy Targeting Delta‐Like Ligand 3 (DLL3), in Patients with Relapsed/Refractory Small Cell Lung Cancer (5
A Population Pharmacokinetic Model of (R)‐ and (S‐) Oxybutynin and Its Active Metabolites After Oral and Intravesical Administration to Healthy Volunteers5
Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure–Response5
Comparative Risks of Nonsteroidal Anti‐inflammatory Drugs on Cardiovascular Diseases: A Population‐Based Cohort Study5
Population Pharmacokinetics and Pharmacodynamics of Burosumab in Adult and Pediatric Patients With X‐linked Hypophosphatemia5
Importance of Target‐Mediated Drug Disposition (TMDD) of Small‐Molecule Compounds and Its Impact on Drug Development—Example of the Class Effect of HSD‐1 Inhibitors5
Minors and a Dawning Paradigm Shift in “Pediatric” Drug Development5
Association Between Baclofen and Respiratory Depression in Patients With Chronic Kidney Disease5
A Retrospective Cohort Study Examining the Effects of Anti‐PD‐1 Antibody in Combination with Apatinib in Patients Previously Treated for Her2‐Negative Advanced Gastric/Gastroesophageal Junction Cancer5
Pooled Population Pharmacokinetic Analyses of Venetoclax in Patients Across Indications and Healthy Subjects from Phase 1, 2, and 3 Clinical Trials5
Inherent Dangers of Using Non–US Food and Drug Administration–Approved Substances of Abuse5
Pharmacokinetics of Ipatasertib in Subjects With Hepatic Impairment Using 2 Methods of Classification of Hepatic Function5
SGLT2 Inhibitors’ Cardiovascular Benefits in Individuals Without Diabetes, Heart Failure, and/or Chronic Kidney Disease: A Systematic Review5
Prenatal Somatic Cell Gene Therapies: Charting a Path Toward Clinical Applications (Proceedings of the CERSI‐FDA Meeting)5
The Importance of Clinical Research in Pregnant Women to Inform Prescription Drug Labeling5
ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies5
Risk of Pregabalin‐Induced Hypoglycemia: Analysis of the Japanese Adverse Drug Event Report Database4
Population Pharmacokinetic Analysis of Brexpiprazole to Support its Indication and Dose Selection in Adolescents With Schizophrenia4
Methotrexate Triglutamate as a Determinant of Clinical Response in Mexican Patients With Rheumatoid Arthritis: Pharmacokinetics and Dose Recommendation4
Model‐Informed Dose Justifications of Posaconazole in Japanese Patients for Prophylaxis and Treatment Against Fungal Infection4
Ceftolozane/Tazobactam Probability of Target Attainment in Patients With Hospital‐Acquired or Ventilator‐Associated Bacterial Pneumonia4
The New S7B/E14 Q&A Document Provides Additional Opportunities to Replace the Thorough QT Study4
Effects of Renal Impairment on the Pharmacokinetics of Gefapixant, a P2X3 Receptor Antagonist4
The Impact of Telmisartan on Cardiometabolic Risk Factors in Hypertensive Male Siblings of Women With Polycystic Ovary Syndrome4
Population Pharmacokinetic Analysis of N‐Acetylcysteine in Pediatric Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplant4
Population Pharmacokinetic‐Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin4
Phase 1 Renal Impairment Trial Results Supports Targeted Individualized Dosing of ELX‐02 in Patients With Nephropathic Cystinosis4
Efficacy and Safety of Lasmiditan for Acute Treatment of Migraine in Adults: A Meta‐Analysis4
Physiologically Based Pharmacokinetics as a Component of Model‐Informed Drug Development: Where We Were, Where We Are, and Where We Are Heading4
Detection of Vaccine Adverse Events Before Package Insert Revisions Using a Japanese Spontaneous Reporting System4
A Drug–Drug Interaction Study of a Novel Selective Urate Reabsorption Inhibitor, SHR4640, and Xanthine Oxidase Inhibitor, Febuxostat, in Patients With Primary Hyperuricemia4
Front‐Line Health Care Professionals Lack Critical Knowledge in Dietary Supplement and Nutraceutical Products: A Call to Action for Comprehensive Educational Opportunities4
Association of ABCC2 Haplotypes to Mycophenolic Acid Pharmacokinetics in Stable Kidney Transplant Recipients4
Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol4
Role of Physiologically Based Pharmacokinetic Modeling and Simulation in Enabling Model‐Informed Development of Drugs and Biotherapeutics4
An Open‐Label, Single‐Arm, Pilot Intervention Study to Assess the Efficacy and Safety of Apixaban in Heparin‐Induced Thrombocytopenia4
Impact of Sex on Clinical Response in Rheumatoid Arthritis Patients Treated With Biologics at Approved Dosing Regimens4
Understanding the Role of Pharmacometrics‐Based Clinical Decision Support Systems in Pediatric Patient Management: A Case Study Using Lyv Software4
Ceftaroline Dosage Optimized for Pediatric Patients With Renal Impairment Using Physiologically Based Pharmacokinetic Modeling4
Gastrointestinal Bleeding During Direct Oral Anticoagulant Therapy in Patients With Nonvalvular Atrial Fibrillation and Risk of Polypharmacy4
Physiologically Based Pharmacokinetic Modeling Characterizes the Drug‐Drug Interaction Between Saxagliptin and Rifampicin in Patients With Renal Impairment4
Pharmacokinetics and Optimal Dose Selection of Cefazolin for Surgical Prophylaxis of Pediatric Patients4
Prediction of Moxifloxacin Concentrations in Tuberculosis Patient Populations by Physiologically Based Pharmacokinetic Modeling4
Dosing Recommendations for Lamotrigine in Children: Evaluation Based on Previous and New Population Pharmacokinetic Models4
Effects of Continuous Albuterol Inhalation on Serum Metabolome in Healthy Subjects: More Than Just Lactic Acid4
Infant Dextromethorphan and Dextrorphan Exposure via Breast Milk From Mothers Who Are CYP2D6 Extensive Metabolizers4
Longitudinal Impact of Acute Spinal Cord Injury on Clinical Pharmacokinetics of Riluzole, a Potential Neuroprotective Agent4
Effect of Mild and Moderate Hepatic Impairment (Defined by Child–Pugh Classification and National Cancer Institute Organ Dysfunction Working Group Criteria) on Pexidartinib Pharmacokinetics4
Hypertensive Crisis Following COVID‐19 Vaccination4
Extension of the Alternative Intravenous Dosing Regimens of Atezolizumab into Combination Settings through Modeling and Simulation4
Reassessing the Pediatric Dosing Recommendations for Unfractionated Heparin Using Real‐World Data: A Pharmacokinetic–Pharmacodynamic Modeling Approach4
Association Between Baseline Use of Angiotensin‐Converting Enzyme Inhibitors and Angiotensin Receptor Blockers and Death Among Patients Tested for COVID‐194
Impact of Multiple Concomitant CYP3A Inhibitors on Venetoclax Pharmacokinetics: A PBPK and Population PK‐Informed Analysis4
Physiologically Based Pharmacokinetic Modeling and Dose Adjustment of Teicoplanin in Pediatric Patients With Renal Impairment4
Regulation of Dietary Supplements and Nutraceutical Products in the United States: An Argument for Greater Oversight and Uniform Standards4
An Empirical Analysis of Japan's Drug Development Lag Behind the United States4
Clinical Pharmacological Reconciliation, Review, and Feedback in Ensuring Patient Safety: A Commentary4
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