Clinical Pharmacology & Therapeutics

Article	Citations
Issue Information	424
Return to SENDer: The Submitted Electronic Data for Nonclinical Cardiovascular Studies is Not Facilitating Transparency, Translation or Innovation	171
Exploring the Association Between Intra‐Patient Variability in Trough Concentration of Pazopanib and Clinical Outcomes in Renal Cell Carcinoma and Soft Tissue Sarcoma Patients	121
In this Issue	102
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An IQ Perspective	99
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FDA Adverse Event Reporting System Essentials: A Reflection on Study Conception	80
Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype‐Guided Precision Medicine	79
Reply to “Interpretation of Pharmacovigilance Disproportionality Analyses”	78
Reply to “Questioning Bayesian Inference‐Based Models for Estimating Culprit Drugs for Adverse Drug Reactions”	70
Model‐Informed Selection of the Recommended Phase 2 Dosage for Anti‐TIGIT Immunotherapy Leveraging co‐Expressed PD‐1 Inhibitor Target Engagement	69
Integrated Evidence Planning for Enhancing Patient Care: Harnessing the Power of Real‐World Evidence	68
Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs	67
Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy Volunteers and Patients with Chronic Kidney Disease	66
The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities	63
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives	62
Machine Learning‐Led Optimization of Combination Therapy: Confronting the Public Health Threat of Extensively Drug Resistant Gram‐Negative Bacteria	58
A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization	54
Frequency of Key Pharmacogenes CYP2C9 , CYP2C19 , CYP2D6	53
Advances in Clinical Therapies for Huntington's Disease and the Promise of Multi‐Targeted/Functional Drugs Based on Clinicaltrials.gov	53
Nicotine Metabolite Ratio Decreases After Switching Off Efavirenz‐Based Therapy in People With HIV Who Smoke	50
Estimating Culprit Drugs for Adverse Drug Reactions Based on Bayesian Inference	49
Drug‐Induced QT Prolongation: Associations Between Risk Classifications in a Swedish Clinical Decision Support System and Clinical Outcomes	48
US Food and Drug Administration's Advancing Real‐World Evidence Program: Initial Experience	47
More Than Pharmacokinetics: Transporters in Clinical Pharmacology	46

ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins – Data in Support of Not Needing Dedicated QTC Studies	45
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID‐19 Under the Emergency Use Authorization	42
Predicting Survival in Patients with Advanced NSCLC Treated with Atezolizumab Using Pre‐ and on‐Treatment Prognostic Biomarkers	42
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Requirements for Phase Lag in First‐In‐Human Trials in India: Proceedings of a Panel Discussion	40
Repeated Intake of Grapefruit Juice Inhibits CYP2B6 , CYP2C9 , CYP2C19	39
Comprehensive Evaluation of OATP‐ and BCRP‐Mediated Drug–Drug Interactions of Methotrexate Using Physiologically‐Based Pharmacokinetic Modeling	39
Denosumab Offers Relatively Lower Initial Protection Against Osteoporotic Vertebral Fractures in Treatment‐Naive Patients Compared With Zoledronate	37
Building Pharmacoequity through Student and Trainee Education, Service, and Global Outreach	37
Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency	37
Why Pediatric CAR ‐T Therapies Still Lag Behind: Insights from Six Treatments Centrally Approved in Europe	35
A Guide for Implementing DPYD Genotyping for Systemic Fluoropyrimidines into Clinical Practice	34
Repurposing Acebutolol for Osteoporosis Treatment: Insights From Multi‐Omics and Multi‐Modal Data Analysis	34
Promise of Quantitative Proteomics in the Qualification of New Approach Methodologies	34
The Broader Context of Liquid Biopsy in Absorption, Distribution, Metabolism, and Elimination	33
Factors Influencing Medication Adherence in Heart Failure Patients—A Survey Among Cardiac Healthcare Providers	33
Repurposing Registries: Completeness of Real‐World Data for Regulatory and HTA Purposes in Three Cancer‐Focused Registries	33
Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned	32
Pharmacogenomic Prescribing Guidelines: Are They Always Useful?	32
From Executor to Orchestrator: The Pharmacology Scientist in the Age of Agentic AI	32
Infection Risk Associated with High‐Efficacy Disease‐Modifying Agents in Multiple Sclerosis: A Retrospective Cohort Study	32
Chinese Expert Consensus on the Clinical Diagnosis and Management of Statin Intolerance	31
French‐Speaking Network of Pharmacogenetics (RNPGx) Recommendations for Clinical Use of Mavacamten	31
Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers	30
Development of Therapeutic Proteins for a New Subcutaneous Route of Administration After the Establishment of Intravenous Dosages: A Systematic Review	30
Using Machine Learning to Individualize Treatment Effect Estimation: Challenges and Opportunities	30
ASCPT News	29
Issue Information	28
Highlights	28
	28
ASCPT News	28
In This Issue	28
ASCPT News	28
ASCPT 125th Anniversary: A Society Leadership Perspective	27
In Memoriam Michelle A. Rudek (1972–2023)	27
Highlighted Articles	27
In this Issue	26
From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology Modeling in Cancer Immunotherapy	26
Pharmacokinetic‐Pharmacodynamic Modeling of the Ponesimod Effect on Heart Rate in Patients With Multiple Sclerosis	26
ASCPT News	26
HIGHLIGHTED ARTICLES	26
Discovering Severe Adverse Reactions From Pharmacokinetic Drug–Drug Interactions Through Literature Analysis and Electronic Health Record Verification	25
A Retrospective Analysis of the Potential Impact of Differences in Aggregates on Clinical Immunogenicity of Biosimilars and their Reference Products	25
PharmVar GeneFocus : NAT2 — Genetic Variation	25
HIV Pharmacology Data Repository: Setting the New Information‐Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies	25
More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations	25
Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors	25
The Future of Machine Learning Within Target Identification: Causality, Reversibility, and Druggability	25
Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma Companies	24
Issue Information	24

Impact of Mercaptopurine Metabolites on Disease Outcome in the AIEOP‐BFM ALL 2009 Protocol for Acute Lymphoblastic Leukemia	24
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer	24
Return of Clinically Actionable Pharmacogenetic Results From Molecular Tumor Board DNA Sequencing Data: Workflow and Estimated Costs	24
Patient‐Specific Determinants of Response to BCMA ‐ and GPRC5D ‐Targeted	23
Navigating Pharmacogenomic Testing in Practice: Who to Test and When to Test	23
Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT2024	23
Assessing Correlation between Surrogate Endpoints and Overall Survival for Oncology Clinical Trials	23
A Case for Synthetic Data in Regulatory Decision‐Making in Europe	23
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation	23
Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after Kidney Transplantation with Population Pharmacokinetic Modeling	22
Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program	21
Piperacillin Population Pharmacokinetics in Plasma and Peritoneal Fluid and Dosing Optimization in Children Undergoing Liver Transplant: An Optimome Study	21
Effect of Late Second to Early Third Trimester of Pregnancy on the Activity of Renal Organic Anion Transporters (OAT1 and OAT3): A Biomarker Study	21
Use of Clinical Pharmacology in Slowing the Myopia Epidemic	21
Clinical Evidence 2030	21
The Framework of Precision Pharmacotherapy in Metabolic Dysfunction‐Associated Steatohepatitis: A Network Meta‐Analysis	21
Optimal Treatment Based on Interferon No Longer Makes Clinical Cure of Chronic Hepatitis B Far Away: An Evidence‐Based Review on Emerging Clinical Data	21
Industry Perspective on First‐in‐Human and Clinical Pharmacology Strategies to Support Clinical Development of T‐Cell Engaging Bispecific Antibodies for Cancer Therapy	21
ESR1 Variants and Subcontinental Genomic Ancestry: Insights from the 1000 Genomes Project and Native American Populations	21
Impact of CYP2C19 Phenotype on Escitalopram Response in Geriatrics: Based on Physiologically‐Based Pharmacokinetic Modeling and Clinical Observation	21
Impact of Dolutegravir‐, Lopinavir/Ritonavir‐, and Efavirenz‐Based Antiretrovirals on Piperaquine Pharmacokinetics in Ugandan Children Living with HIV	21
Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development	20
Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites	20
Issue Information	20
Model‐Informed Drug Development Supports Full Approval of Ibuprofen Injection in Chinese Pediatric Patients With Fever or Pain	20
The Impact of QT‐Prolonging Medications and Drug–Drug Interactions on QTc Interval Prolongation in Hospitalized Patients: A Case‐Crossover Study	20
Trust in the Food and Drug Administration: A National Survey Study	20
Carbon Footprint of Antibody‐Based Drugs and Biologics Using Hybrid Life Cycle Assessment	20
Biomarker Utilization for Regulatory Decision Making: A Landscape Analysis of Neurological Drug Products Approved by FDA (2008–2024)	19
Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024	19
Thiopurine Methyltransferase Intermediate Metabolizer Status and Thiopurine‐Associated Toxicity During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia	19
Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population‐Based Cohort Study	19
Ocular Complications of SGLT ‐2 Inhibitors, GLP ‐1 Receptor Agonists, and	19
Highlighted Articles	19
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All	19
Clinical and Quantitative Pharmacology Considerations of mRNA Therapeutics and Vaccine Development: Bridging Translational and Platform Gaps for Enha	19
Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database	19
Physiologically Based Pharmacokinetic Modeling to Investigate the Disease‐Drug–Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID‐19 Patients with CYP2C19	19
Safety and Dosing Study of a Cholecystokinin Receptor Antagonist in Non‐alcoholic Steatohepatitis	19
Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection	19
Emulating Comparative Oncology Trials With Real‐World Evidence Studies ( ENCORE ): Process Development and Methodological Considerations for Oncology	19
Participants in the FDA's Biomarker Qualification Program	19
Regulatory Issues of Platform Trials: Learnings from EU‐PEARL	19
Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level	18
Model‐Informed Approach to Recommend Burosumab Dosing Regimens for Pediatric and Adult Patients With the Ultrarare Disease Tumor‐Induced Osteomalacia	18
Is Liquid Biopsy Only Restricted to Diagnostics or Can it Go Beyond the Confines of Genotyping and Phenotyping for Quantitative Pharmacology?	18
Pathway‐Informed Machine Learning Identifies Genetic Predictors of High‐Dose Methotrexate‐Induced Mucositis in Pediatric Acute Lymphoblastic Leukemia	18
Model‐Informed Drug Development: Steps Toward Harmonized Guidance	18
Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda	18
Multi‐Omics Studies in Historically Excluded Populations: The Road to Equity	18
Aging‐Related CYP3A Functional Changes in Chinese Older Patients: New Findings from Model‐Based Assessment of Amlodipine	17
Progress in Pharmacogenomics Implementation in the United States: Barrier Erosion and Remaining Challenges	17
Issue Information	17
From Models to Meaning: The Integrator Pharmacologist's Role in Advancing Health Equity Across the Drug Development Continuum	17
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease	17
Highlights	17
A Metabolomic Analysis of Sensitivity and Specificity of 23 Previously Proposed Biomarkers for Renal Transporter‐Mediated Drug‐Drug Interactions	17
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Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective	17
Optimal Drug, Optimal Dose, or Both in the Pharmacological Treatment of Neonatal Opioid Withdrawal Syndrome?	16
Issue Information	16
Revisiting Tirzepatide’s Body Composition Model: Underestimated Fat‐Free Mass Loss and Clinical Implications	16
Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5‐Year Retrospective Analysis	16
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Changes in Protein Expression of Renal Drug Transporters and Drug‐Metabolizing Enzymes in Autosomal Dominant Polycystic Kidney Disease Patients	16
Optimizing Dosage in Pharmacotherapy—Missing the Forest for the Trees	16
Real‐World Edoxaban Concentrations in Older Patients Receiving Reduced‐Dose Regimens	16
Population Pharmacokinetic and Exposure–Response Analyses for Efficacy and Safety of Risankizumab in Patients With Active Crohn's Disease	16
ASCPT News	16
Abstracts	16
Comparative Intra‐Subject Analysis of Gene Expression and Protein Abundance of Major and Minor Drug Metabolizing Enzymes in Healthy Human Jejunum and Liver	16
An Evaluation of the Drug Interaction Potential of Encorafenib in Combination With Binimetinib Using the Inje Cocktail in Patients With Cancer	16
The Type of Follicle‐Stimulating Hormone Medication Given for In Vitro Fertilization Impacts Oocyte Retrieval: A Systematic Review and Meta‐Analysis	16
Implementation of NUDT15 Genotyping to Prevent Azathioprine‐Induced Leukopenia for Patients With Autoimmune Disorders in Chinese Population	15
Intelligent Automation Improved Efficiency in Pharmacovigilance Safety Signal Assessment	15
Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology	15
Warfarin‐Rifampin‐Gene (WARIF‐G) Interaction: A Retrospective, Genetic, Case–Control Study	15
Personalizing Direct Oral Anticoagulant Therapy for a Diverse Population: Role of Race, Kidney Function, Drug Interactions, and Pharmacogenetics	15
Model‐Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated	15
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions	15

Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper	15
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Ticagrelor versus Adjusted‐Dose Prasugrel in Acute Coronary Syndrome with Percutaneous Coronary Intervention	15
Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?	15
Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real‐World Data Sources for Fit‐for‐Purpose Studies	15
Development in Prescriptions of Contraindicated and Potentially Harmful QT Interval–Prolonging Drugs in a Large Geriatric Inpatient Cohort From 2011 to 2021	15
Challenges and Possible Strategies to Address Them in Rare Disease Drug Development: A Statistical Perspective	15
Highlighted Articles	15
A Nomogram to Predict Severe Toxicity in DPYD Wild‐Type Patients Treated With Capecitabine‐Based Anticancer Regimens	15
The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making	15
Clinical Actionability of the NUDT15 *4 (p.R139H) Allele and Its Association With Hispanic Ethnicity	15
Assessment of Efficacy Evidence for Approvals of Novel Drugs in China Between 2018 and 2022	15
Prescriber Adoption of SLCO1B1Genotype‐Guided Simvastatin Clinical Decision Support in a Clinical Pharmacogenetics Program	14
ASCPT News	14
A Comment about AI Methods that May Help Advance Pharmacovigilance	14
In this Issue	14
Prediction of Busulfan Clearance by Predose Plasma Metabolomic Profiling	14
Progress in Clinical Pharmacology in China: An Ongoing Evolution	14
Implementation of DPYD Genotyping in Admixed American Populations: Brazil as a Model Case	14
Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity	14
ASCPT News	14
American Society for Clinical Pharmacology and Therapeutics	14
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics	14
Is a Clinical Trial With a Non‐Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK	14
In This Issue	14
Population Pharmacokinetic Modeling of Glycochenodeoxycholic Acid 3‐O‐Sulfate ( GCDCA ‐S) as Endogenous Biomarker of OATP1B3	14
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical Development	14
Population Pharmacokinetics of Intravenous Methadone Enantiomers in Adults: A Comprehensive Model	14
Issue Information	14
Population Pharmacokinetic and Exposure‐Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post‐Exposure Prophylaxis in Children	14
Highlights	14
Response to “Misuse of the Term Biorhythms Undermines Chronological Research”	14
Advancing Maternal Health with Long‐Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging Technologies	13
Quantitative Systems Toxicology Predicts Ivacaftor‐Induced Oxidative Stress Contributes to CFTR Modulator Hepatotoxicity	13
Real‐World Safety of JAK Inhibitors in Skin Immune‐Mediated Inflammatory Diseases: Boxed Warning Outcomes from a Multinational Cohort Study	13
PBPK Modeling of Entrectinib and Its Active Metabolite to Derive Dose Adjustments in Pediatric Populations Co‐Administered with CYP3A4 Inhibitors	13
Biomarkers of Drug‐Induced Kidney Injury: Use in Clinical Trials and Recent Examples of Impact on Drug Development	13
Population Pharmacokinetics of siRNA JNJ ‐73763989 in Healthy Participants and Patients With Chronic Hepatitis B	13
Guided Sample Pooling in Human Mass Balance Studies: A Recommended Strategic Decision Framework	13
A Comparison of Regional Decisions for Doses and Administrations of New Drugs: Concordance, Discordance, and Dependencies	13
Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology	13
How to Run the Pharmacogenomics Clinical Annotation Tool (PharmCAT)	13
Effects of Fomepizole on Acetaminophen Oxidative Metabolism: A Randomized, Crossover Study in Human Volunteers	13
How Much More Efficient Are Adaptive Platform Trials Than Multiple Stand‐Alone Trials? A Comprehensive Simulation Study for Streamlining Drug Development During a Pandemic	13
Moving Toward a Question‐Centric Approach for Regulatory Decision Making in the Context of Drug Assessment	13
Tacrolimus and Mycophenolic Acid Exposure Are Associated with Biopsy‐Proven Acute Rejection: A Study to Provide Evidence for Longer‐Term Target Ranges	13
Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo‐controlled Trial in Constipation	13
A Quantitative Systems Pharmacology Model Describing the Cellular Kinetic‐Pharmacodynamic Relationship for a Live Biotherapeutic Product to Support Microbiome Drug Development	13
Development and Validation of the Pharmacological Statin‐Associated Muscle Symptoms Risk Stratification Score Using Electronic Health Record Data	13
Quantitative Systems Toxicology Modeling Informed Safe Dose Selection of Emvododstat in Acute Myeloid Leukemia Patients	13
In This Issue	13
Prognostic Implication of CYP2C19 Genotype According to Clinical Risk Stratification After Drug‐Eluting Stent Implantation	13
Crossing the Chasm: How to Approach Translational Pharmacokinetic–Pharmacodynamic Modeling of Phage Dosing	13
Cardiovascular Safety of Febuxostat vs. Allopurinol in Gout Patients with Cardiovascular Diseases: A Target Trial Emulation	12
Use of FDA Expedited Programs and Development Timelines for New Molecular Entity Drug and New Biologic Approvals by Sponsor Experience	12
Dose Titration of Ixazomib Maintenance Therapy in Transplant‐Ineligible Multiple Myeloma: Exposure–Response Analysis of the TOURMALINE‐MM4 Study	12
Breaking Barriers: Characterization of the Intradermal Lipopolysaccharide Challenge as an In Vivo Model for Controlled Induction of Vascular Leakage in H	12
Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer	12
A Multistakeholder Perspective on Advancing Individualized Therapeutics	12
Populations Addressed in Vaccines Approved via the European Medicines Agency	12
Successes and Opportunities during the Pandemic: Reflections and Revelations from a Vaccine Development Perspective	12
Keyword Index	12
Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After Nephrotoxic and Ischemic Injury	12
A Comparative Clinical Pharmacology Analysis of FDA‐Approved Targeted Covalent Inhibitors vs. Reversible Inhibitors in Oncology	12
From Classical PKPD to Model‐Informed Drug Development: Are “Digital Twins” a New Paradigm?	12
In this Issue	12
Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With Concomitant Rifampicin: A Dose Escalation Study	12
Challenging the Detection of Comedication Interactions Related to Immune‐Related Adverse Events Using Spontaneous Reporting Systems	12
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COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study	12
Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage Optimization for Patients with Renal Insufficiency or Receiving Continuous Renal Replacement Therapy	12
ASCPT News	12
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Drug Interactions Brewing	12
Causal Effects of Hydrophilic Bile Acids on Carfilzomib‐Related Cardiovascular Events in Multiple Myeloma: A Mendelian Randomization Study	12
Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group‐Pediatr	12
Population Pharmacokinetics and Exposure–Response Analysis for the CTLA‐4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study	12
Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft‐Versus‐Host Disease	12
Role of Cytochrome P450 2C8 in Drug–Drug Interaction between Amiodarone and Nirmatrelvir/Ritonavir Via Physiologically‐Based Pharmacokinetic Modeling	12
Issue Information	12
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Highlights	11
Folinic Acid Prophylaxis and Dose Adjustments Enable Safe Treatment with Pemetrexed in Patients with Renal Impairment	11
Risk of Acute Kidney Injury Associated With Nephrotoxic Burden in Hospitalized Patients: A Scoping Review	11
Psychedelics and Psychotherapy: Is the Whole Greater than the Sum of its Parts?	11
Post‐Approval Pediatric Use of Drugs Granted Waivers from Pediatric Testing	11
Emerging Tools and Technologies for Microbiome‐Aware Drug Development	11
Issue Information	11
ASCPT NEWS	11
Promoting Pharmacogenomics in Africa: Perspectives From Variation in G6PD and Other Pharmacogenes	11
Clinical Pharmacogenomic MT‐RNR1 Screening for Aminoglycoside‐Induced Ototoxicity and the Post‐Test Counseling Conundrum	11
Pharmacokinetic Enhancement of Elexacaftor/Tezacaftor/Ivacaftor for Cystic Fibrosis: A Cost Reduction Strategy to Address Global Disparities in Access	11
Model‐Informed Drug Development‐Based Bridging from Subcutaneous to Intravenous Secukinumab Dosing: Approval in Psoriatic Arthritis and Axial Spondyloarthritis	11
The Future of Clinical Translational Pharmacology	11
Population Genomics Insights into Pharmacogenomic Differentiation Between East Asians and Europeans	11