Clinical Pharmacology & Therapeutics

Article	Citations
Issue Information	339
Return to SENDer: The Submitted Electronic Data for Nonclinical Cardiovascular Studies is Not Facilitating Transparency, Translation or Innovation	261
Exploring the Association Between Intra‐Patient Variability in Trough Concentration of Pazopanib and Clinical Outcomes in Renal Cell Carcinoma and Soft Tissue Sarcoma Patients	251
Machine Learning‐Led Optimization of Combination Therapy: Confronting the Public Health Threat of Extensively Drug Resistant Gram‐Negative Bacteria	216
In this Issue	139
ASCPT News	124
In This Issue	120
Estimating Culprit Drugs for Adverse Drug Reactions Based on Bayesian Inference	116
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French‐Speaking Network of Pharmacogenetics (RNPGx) Recommendations for Clinical Use of Mavacamten	110
FDA Adverse Event Reporting System Essentials: A Reflection on Study Conception	95
Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy Volunteers and Patients with Chronic Kidney Disease	95
A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization	89
Promise of Quantitative Proteomics in the Qualification of New Approach Methodologies	80
A Guide for Implementing DPYD Genotyping for Systemic Fluoropyrimidines into Clinical Practice	74
Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs	66
More Than Pharmacokinetics: Transporters in Clinical Pharmacology	63
Comprehensive Evaluation of OATP‐ and BCRP‐Mediated Drug–Drug Interactions of Methotrexate Using Physiologically‐Based Pharmacokinetic Modeling	62
Factors Influencing Medication Adherence in Heart Failure Patients—A Survey Among Cardiac Healthcare Providers	61
Infection Risk Associated with High‐Efficacy Disease‐Modifying Agents in Multiple Sclerosis: A Retrospective Cohort Study	60
Predicting Survival in Patients with Advanced NSCLC Treated with Atezolizumab Using Pre‐ and on‐Treatment Prognostic Biomarkers	56
US Food and Drug Administration's Advancing Real‐World Evidence Program: Initial Experience	55
Advances in Clinical Therapies for Huntington's Disease and the Promise of Multi‐Targeted/Functional Drugs Based on Clinicaltrials.gov	52
A Biological Basis for Pharmacokinetics: The Remote Sensing and Signaling Theory	51
Nicotine Metabolite Ratio Decreases After Switching Off Efavirenz‐Based Therapy in People With HIV Who Smoke	49

Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency	49
Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers	49
Repurposing Acebutolol for Osteoporosis Treatment: Insights From Multi‐Omics and Multi‐Modal Data Analysis	46
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An IQ Perspective	45
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives	44
The Broader Context of Liquid Biopsy in Absorption, Distribution, Metabolism, and Elimination	44
Chinese Expert Consensus on the Clinical Diagnosis and Management of Statin Intolerance	44
Longitudinal Model‐Based Meta‐Analysis of Lung Function Response to Support Phase III Study Design in Chinese Patients With Asthma	44
Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype‐Guided Precision Medicine	43
Protecting the Kidney: The Unexpected Logic of Inhibiting a Glucose Transporter	42
Model‐Informed Selection of the Recommended Phase 2 Dosage for Anti‐TIGIT Immunotherapy Leveraging co‐Expressed PD‐1 Inhibitor Target Engagement	41
Reply to “Questioning Bayesian Inference‐Based Models for Estimating Culprit Drugs for Adverse Drug Reactions”	41
Reply to “Interpretation of Pharmacovigilance Disproportionality Analyses”	41
Integrated Evidence Planning for Enhancing Patient Care: Harnessing the Power of Real‐World Evidence	39
Model‐Based Prediction of Irinotecan‐Induced Grade 4 Neutropenia in Advanced Cancer Patients: Influence of Demographic and Clinical Factors	39
Liquid Biopsies or Therapeutic Drug Monitoring for CYP Activity Profile Determination	38
How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example	37
Development of Therapeutic Proteins for a New Subcutaneous Route of Administration After the Establishment of Intravenous Dosages: A Systematic Review	37
PharmVar GeneFocus: CYP3A5	37
Effect of CYP3A5 and CYP3A4 Genetic Variants on Fentanyl Pharmacokinetics in a Pediatric Population	36
Using Machine Learning to Individualize Treatment Effect Estimation: Challenges and Opportunities	35
Neurodegenerative Diseases: The Value of Early Predictive End Points	35
Pharmacogenomic Prescribing Guidelines: Are They Always Useful?	34
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID‐19 Under the Emergency Use Authorization	34
Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned	33
The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities	33
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	33
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ASCPT News	32
ASCPT News	31
In This Issue	31
ASCPT News	31
Issue Information	31
Highlights	31
Assessing Correlation between Surrogate Endpoints and Overall Survival for Oncology Clinical Trials	30
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Navigating Pharmacogenomic Testing in Practice: Who to Test and When to Test	29
In Memoriam Michelle A. Rudek (1972–2023)	29
ASCPT 125th Anniversary: A Society Leadership Perspective	29
Pharmacokinetic‐Pharmacodynamic Modeling of the Ponesimod Effect on Heart Rate in Patients With Multiple Sclerosis	29
ASCPT News	29
Highlighted Articles	29
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation	29
In this Issue	29
HIV Pharmacology Data Repository: Setting the New Information‐Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies	29
HIGHLIGHTED ARTICLES	28
Return of Clinically Actionable Pharmacogenetic Results From Molecular Tumor Board DNA Sequencing Data: Workflow and Estimated Costs	28
Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT2024	28
Development of a Translational Exposure‐Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products	27
The Future of Machine Learning Within Target Identification: Causality, Reversibility, and Druggability	27

ESR1 Variants and Subcontinental Genomic Ancestry: Insights from the 1000 Genomes Project and Native American Populations	27
Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors	27
Impact of CYP2C19 Phenotype on Escitalopram Response in Geriatrics: Based on Physiologically‐Based Pharmacokinetic Modeling and Clinical Observation	27
A Case for Synthetic Data in Regulatory Decision‐Making in Europe	27
Discovering Severe Adverse Reactions From Pharmacokinetic Drug–Drug Interactions Through Literature Analysis and Electronic Health Record Verification	26
Industry Perspective on First‐in‐Human and Clinical Pharmacology Strategies to Support Clinical Development of T‐Cell Engaging Bispecific Antibodies for Cancer Therapy	26
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer	26
The Impact of QT‐Prolonging Medications and Drug–Drug Interactions on QTc Interval Prolongation in Hospitalized Patients: A Case‐Crossover Study	25
Trust in the Food and Drug Administration: A National Survey Study	25
From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology Modeling in Cancer Immunotherapy	25
Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma Companies	25
Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after Kidney Transplantation with Population Pharmacokinetic Modeling	25
Optimal Treatment Based on Interferon No Longer Makes Clinical Cure of Chronic Hepatitis B Far Away: An Evidence‐Based Review on Emerging Clinical Data	25
Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program	24
Impact of Mercaptopurine Metabolites on Disease Outcome in the AIEOP‐BFM ALL 2009 Protocol for Acute Lymphoblastic Leukemia	24
A Retrospective Analysis of the Potential Impact of Differences in Aggregates on Clinical Immunogenicity of Biosimilars and their Reference Products	24
New and Emerging Research on Solute Carrier and ATP Binding Cassette Transporters in Drug Discovery and Development: Outlook From the International Transporter Consortium	24
Clinical Evidence 2030	23
Model‐Informed Approach to Recommend Burosumab Dosing Regimens for Pediatric and Adult Patients With the Ultrarare Disease Tumor‐Induced Osteomalacia	23
Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development	23
Drug Disposition Protein Quantification in Matched Human Jejunum and Liver From Donors With Obesity	23
Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population‐Based Cohort Study	23
Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value	23
Issue Information	23
Safety and Dosing Study of a Cholecystokinin Receptor Antagonist in Non‐alcoholic Steatohepatitis	23
Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda	22
Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection	22
Physiologically Based Pharmacokinetic Modeling to Investigate the Disease‐Drug–Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID‐19 Patients with CYP2C19	22
Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024	22
Multi‐Omics Studies in Historically Excluded Populations: The Road to Equity	22
Aging‐Related CYP3A Functional Changes in Chinese Older Patients: New Findings from Model‐Based Assessment of Amlodipine	22
Clinical and Quantitative Pharmacology Considerations of mRNA Therapeutics and Vaccine Development: Bridging Translational and Platform Gaps for Enhanced Decision Making	22
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All	21
Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites	21
Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level	21
Ocular Complications of SGLT‐2 Inhibitors, GLP‐1 Receptor Agonists, and DPP‐4 Inhibitors in T2DM Treatments: A Retrospective Real‐World Cohort Study	21
Highlighted Articles	21
Progress in Pharmacogenomics Implementation in the United States: Barrier Erosion and Remaining Challenges	20
Is Liquid Biopsy Only Restricted to Diagnostics or Can it Go Beyond the Confines of Genotyping and Phenotyping for Quantitative Pharmacology?	20
Model‐Informed Drug Development: Steps Toward Harmonized Guidance	20
A Metabolomic Analysis of Sensitivity and Specificity of 23 Previously Proposed Biomarkers for Renal Transporter‐Mediated Drug‐Drug Interactions	20
Thiopurine Methyltransferase Intermediate Metabolizer Status and Thiopurine‐Associated Toxicity During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia	20
Participants in the FDA's Biomarker Qualification Program	20
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?	19
Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective	19
Biomarker Utilization for Regulatory Decision Making: A Landscape Analysis of Neurological Drug Products Approved by FDA (2008–2024)	19
Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database	19
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Regulatory Issues of Platform Trials: Learnings from EU‐PEARL	19
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease	19
Highlights	18
The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making	18
Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5‐Year Retrospective Analysis	18
Changes in Protein Expression of Renal Drug Transporters and Drug‐Metabolizing Enzymes in Autosomal Dominant Polycystic Kidney Disease Patients	18
Highlights	18
Optimal Drug, Optimal Dose, or Both in the Pharmacological Treatment of Neonatal Opioid Withdrawal Syndrome?	18
Development in Prescriptions of Contraindicated and Potentially Harmful QT Interval–Prolonging Drugs in a Large Geriatric Inpatient Cohort From 2011 to 2021	18
Assessment of Efficacy Evidence for Approvals of Novel Drugs in China Between 2018 and 2022	18
ASCPT News	18
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Issue Information	18
A Nomogram to Predict Severe Toxicity in DPYD Wild‐Type Patients Treated With Capecitabine‐Based Anticancer Regimens	18
The Type of Follicle‐Stimulating Hormone Medication Given for In Vitro Fertilization Impacts Oocyte Retrieval: A Systematic Review and Meta‐Analysis	17
Revisiting Tirzepatide's Body Composition Model: Underestimated Fat‐Free Mass Loss and Clinical Implications	17
Clinical Actionability of the NUDT15 *4 (p.R139H) Allele and Its Association With Hispanic Ethnicity	17
Optimizing Dosage in Pharmacotherapy—Missing the Forest for the Trees	17
Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology	17
Abstracts	17
Warfarin‐Rifampin‐Gene (WARIF‐G) Interaction: A Retrospective, Genetic, Case–Control Study	17
Comparative Intra‐Subject Analysis of Gene Expression and Protein Abundance of Major and Minor Drug Metabolizing Enzymes in Healthy Human Jejunum and Liver	17
Challenges and Possible Strategies to Address Them in Rare Disease Drug Development: A Statistical Perspective	17
Issue Information	17
Ticagrelor versus Adjusted‐Dose Prasugrel in Acute Coronary Syndrome with Percutaneous Coronary Intervention	16
Pharmacogenomic Clinical Decision Support: A Scoping Review	16
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions	16
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Population Pharmacokinetics of siRNA JNJ‐73763989 in Healthy Participants and Patients With Chronic Hepatitis B	16
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Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study	16
Implementation of NUDT15 Genotyping to Prevent Azathioprine‐Induced Leukopenia for Patients With Autoimmune Disorders in Chinese Population	16

Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID‐19 Trial of Nirmatrelvir	16
Highlighted Articles	16
In this Issue	16
Issue Information	16
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective	16
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper	16
Population Pharmacokinetic and Exposure–Response Analyses for Efficacy and Safety of Risankizumab in Patients With Active Crohn's Disease	16
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	16
ASCPT News	16
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Personalizing Direct Oral Anticoagulant Therapy for a Diverse Population: Role of Race, Kidney Function, Drug Interactions, and Pharmacogenetics	16
Progress in Clinical Pharmacology in China: An Ongoing Evolution	15
Moving Toward a Question‐Centric Approach for Regulatory Decision Making in the Context of Drug Assessment	15
Highlights	15
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical Development	15
Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo‐controlled Trial in Constipation	15
ASCPT News	15
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics	15
Quantitative Systems Toxicology Predicts Ivacaftor‐Induced Oxidative Stress Contributes to CFTR Modulator Hepatotoxicity	14
How Much More Efficient Are Adaptive Platform Trials Than Multiple Stand‐Alone Trials? A Comprehensive Simulation Study for Streamlining Drug Development During a Pandemic	14
Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity	14
Population Pharmacokinetic Modeling of Glycochenodeoxycholic Acid 3‐O‐Sulfate (GCDCA‐S) as Endogenous Biomarker of OATP1B3 and OAT3 Transporters	14
A Quantitative Systems Pharmacology Model Describing the Cellular Kinetic‐Pharmacodynamic Relationship for a Live Biotherapeutic Product to Support Microbiome Drug Development	14
Prediction of Busulfan Clearance by Predose Plasma Metabolomic Profiling	14
Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage Optimization for Patients with Renal Insufficiency or Receiving Continuous Renal Replacement Therapy	14
PBPK Modeling of Entrectinib and Its Active Metabolite to Derive Dose Adjustments in Pediatric Populations Co‐Administered with CYP3A4 Inhibitors	14
Response to “Misuse of the Term Biorhythms Undermines Chronological Research”	14
Development and Validation of the Pharmacological Statin‐Associated Muscle Symptoms Risk Stratification Score Using Electronic Health Record Data	14
Prescriber Adoption of SLCO1B1Genotype‐Guided Simvastatin Clinical Decision Support in a Clinical Pharmacogenetics Program	14
Crossing the Chasm: How to Approach Translational Pharmacokinetic–Pharmacodynamic Modeling of Phage Dosing	14
Tacrolimus and Mycophenolic Acid Exposure Are Associated with Biopsy‐Proven Acute Rejection: A Study to Provide Evidence for Longer‐Term Target Ranges	14
Immune Checkpoint Inhibitors and Venous Thromboembolism: An Analysis of the WHO Pharmacovigilance Database	14
Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After Nephrotoxic and Ischemic Injury	14
Implementation of DPYD Genotyping in Admixed American Populations: Brazil as a Model Case	14
How to Run the Pharmacogenomics Clinical Annotation Tool (PharmCAT)	14
Drug Interactions Brewing	13
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib	13
Successes and Opportunities during the Pandemic: Reflections and Revelations from a Vaccine Development Perspective	13
Keyword Index	13
ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs	13
Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019	13
Clinical Pharmacogenomic MT‐RNR1 Screening for Aminoglycoside‐Induced Ototoxicity and the Post‐Test Counseling Conundrum	13
Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With Concomitant Rifampicin: A Dose Escalation Study	13
A Comparative Clinical Pharmacology Analysis of FDA‐Approved Targeted Covalent Inhibitors vs. Reversible Inhibitors in Oncology	13
The Pandemic as a Catalyst for Disruptive Innovation in Clinical Pharmacology	13
Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology	13
Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic	13
Folinic Acid Prophylaxis and Dose Adjustments Enable Safe Treatment with Pemetrexed in Patients with Renal Impairment	13
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Mitigating Drug–Target–Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors	13
A Multistakeholder Perspective on Advancing Individualized Therapeutics	13
Issue Information	13
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Quantitative Systems Toxicology Modeling Informed Safe Dose Selection of Emvododstat in Acute Myeloid Leukemia Patients	13
ASCPT News	13
Population Pharmacokinetics and Exposure–Response Analysis for the CTLA‐4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study	12
Promoting Pharmacogenomics in Africa: Perspectives From Variation in G6PD and Other Pharmacogenes	12
Emerging Tools and Technologies for Microbiome‐Aware Drug Development	12
Ziritaxestat Drug–Drug Interaction with Oral Contraceptives: Role of SULT1E1 Inhibition	12
Pharmacokinetic Enhancement of Elexacaftor/Tezacaftor/Ivacaftor for Cystic Fibrosis: A Cost Reduction Strategy to Address Global Disparities in Access	12
Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer	12
Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft‐Versus‐Host Disease	12
Model‐Informed Precision Dosing Using Machine Learning for Levothyroxine in General Practice: Development, Validation and Clinical Simulation Trial	12
Populations Addressed in Vaccines Approved via the European Medicines Agency	12
A Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Insulin Dimer	12
Effect of Chronic Hepatitis C on the Activity of the Membrane Transporters P‐gp and OATP1B1/BCRP on Patients With Different Stages of Hepatic Fibrosis	12
Physiologically Based Pharmacokinetic Modeling to Determine the Impact of CYP2B6 Genotype on Efavirenz Exposure in Children, Mothers and Breastfeeding Infants	12
Japan's Conditional/Time‐Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets	12
A Pharmacometric Method for Quantitative Determination of Improvement in Body Composition and Characterization of the Exposure–Response Relationship during Treatment of Obesity with Tirzepatide	12
COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study	12
Investigational Use of Real‐World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma From the Randomized Phase Ib/II MORPHEUS Trial	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
Dose Titration of Ixazomib Maintenance Therapy in Transplant‐Ineligible Multiple Myeloma: Exposure–Response Analysis of the TOURMALINE‐MM4 Study	12
Role of Cytochrome P450 2C8 in Drug–Drug Interaction between Amiodarone and Nirmatrelvir/Ritonavir Via Physiologically‐Based Pharmacokinetic Modeling	12
Precision Reimbursement for Precision Medicine: Using Real‐World Evidence to Evolve From Trial‐and‐Project to Track‐and‐Pay to Learn‐and‐Predict	12
TMS and EEG Pharmacodynamic Effects of a Selective Sphingosine‐1‐Phosphate Subtype 1 Receptor Agonist on Cortical Excitability in Healthy Subjects	12
Use of FDA Expedited Programs and Development Timelines for New Molecular Entity Drug and New Biologic Approvals by Sponsor Experience	12
Impact of the ABCD‐GENE Score on Clopidogrel Clinical Effectiveness after PCI: A Multi‐Site, Real‐World Investigation	12
Model‐Informed Drug Development‐Based Bridging from Subcutaneous to Intravenous Secukinumab Dosing: Approval in Psoriatic Arthritis and Axial Spondyloarthritis	12
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Issue Information	11
Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase	11
The Persistent Ambiguity of Adverse Drug Reactions	11
Response to: Real‐World Data on the Risk of Ventricular Arrhythmias with Sulfonamides	11
Polygenic Risk Scores for Blood Pressure to Assess the Risk of Severe Bevacizumab‐Induced Hypertension in Cancer Patients (Alliance)	11
Highlights	11
Mycophenolic Acid Exposure Determines Antibody Formation Following SARS‐CoV‐2 Vaccination in Kidney Transplant Recipients: A Nested Cohort Study	11
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Model‐Informed Precision Dosing of Busulfan for Children and Adults Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: A Critical Evaluation of Current PK Models and Dose Recomm	11
Regulator‐Requested Non‐Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review	11
ASCPT NEWS	11
Translational Modeling as a Tool to Evaluate the Effectiveness of Nalmefene in a Community Setting: A Critical Perspective	11
The Use of Real‐World Evidence for Regulatory Decisions in China	11
Current Perspectives on Data Sharing and Open Science in Pharmacogenomics	11
Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Studies Related to Vincristine‐Induced Peripheral Neuropathy in Chinese Pediatric ALL Patients	11