Clinical Pharmacology & Therapeutics

Article	Citations
Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real‐world Data Results from the AlcalUN Study	499
Return to SENDer: The Submitted Electronic Data for Nonclinical Cardiovascular Studies is Not Facilitating Transparency, Translation or Innovation	283
Issue Information	228
In This Issue	193
ASCPT News	185
In This Issue	126
In this Issue	112
Model‐Based Prediction of Irinotecan‐Induced Grade 4 Neutropenia in Advanced Cancer Patients: Influence of Demographic and Clinical Factors	108
Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy Volunteers and Patients with Chronic Kidney Disease	105
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French‐Speaking Network of Pharmacogenetics (RNPGx) Recommendations for Clinical Use of Mavacamten	93
Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B‐Cell Hematological Malignancies	87
Factors Influencing Medication Adherence in Heart Failure Patients—A Survey Among Cardiac Healthcare Providers	84
Model‐Informed Selection of the Recommended Phase 2 Dosage for Anti‐TIGIT Immunotherapy Leveraging co‐Expressed PD‐1 Inhibitor Target Engagement	84
Integrated Evidence Planning for Enhancing Patient Care: Harnessing the Power of Real‐World Evidence	83
Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency	69
Chinese Expert Consensus on the Clinical Diagnosis and Management of Statin Intolerance	69
PharmVar GeneFocus: CYP3A5	64
US Food and Drug Administration's Advancing Real‐World Evidence Program: Initial Experience	64
Pharmacogenomic Prescribing Guidelines: Are They Always Useful?	62
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID‐19 Under the Emergency Use Authorization	61
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	59
Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype‐Guided Precision Medicine	56
Nicotine Metabolite Ratio Decreases After Switching Off Efavirenz‐Based Therapy in People With HIV Who Smoke	56
Machine Learning‐Led Optimization of Combination Therapy: Confronting the Public Health Threat of Extensively Drug Resistant Gram‐Negative Bacteria	55

Advances in Clinical Therapies for Huntington's Disease and the Promise of Multi‐Targeted/Functional Drugs Based on Clinicaltrials.gov	52
A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization	52
Comprehensive Evaluation of OATP‐ and BCRP‐Mediated Drug–Drug Interactions of Methotrexate Using Physiologically‐Based Pharmacokinetic Modeling	51
Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned	50
Protecting the Kidney: The Unexpected Logic of Inhibiting a Glucose Transporter	49
Effect of CYP3A5 and CYP3A4 Genetic Variants on Fentanyl Pharmacokinetics in a Pediatric Population	48
More Than Pharmacokinetics: Transporters in Clinical Pharmacology	47
Estimating Culprit Drugs for Adverse Drug Reactions Based on Bayesian Inference	46
Development of Therapeutic Proteins for a New Subcutaneous Route of Administration After the Establishment of Intravenous Dosages: A Systematic Review	45
Reply to “Interpretation of Pharmacovigilance Disproportionality Analyses”	45
Reply to “Questioning Bayesian Inference‐Based Models for Estimating Culprit Drugs for Adverse Drug Reactions”	45
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An IQ Perspective	45
DrugWAS: Drug‐wide Association Studies for COVID‐19 Drug Repurposing	44
Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs	42
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives	40
The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities	39
How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example	39
Using Machine Learning to Individualize Treatment Effect Estimation: Challenges and Opportunities	38
Predicting Survival in Patients with Advanced NSCLC Treated with Atezolizumab Using Pre‐ and on‐Treatment Prognostic Biomarkers	38
A Biological Basis for Pharmacokinetics: The Remote Sensing and Signaling Theory	37
Infection Risk Associated with High‐Efficacy Disease‐Modifying Agents in Multiple Sclerosis: A Retrospective Cohort Study	37
Liquid Biopsies or Therapeutic Drug Monitoring for CYP Activity Profile Determination	37
A Guide for Implementing DPYD Genotyping for Systemic Fluoropyrimidines into Clinical Practice	37
Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers	37
Neurodegenerative Diseases: The Value of Early Predictive End Points	37
The Broader Context of Liquid Biopsy in Absorption, Distribution, Metabolism, and Elimination	36
Longitudinal Model‐Based Meta‐Analysis of Lung Function Response to Support Phase III Study Design in Chinese Patients With Asthma	36
ASCPT News	35
In this Issue	35
Optimized Alectinib Dose Regimen for Treatment of Patients With ALK‐Positive Non‐Small Cell Lung Cancer Based on Robust Pharmacometric Analyses and Clinical Evidence	34
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ASCPT News	34
ASCPT News	33
Highlights	33
CYP2D6*9 and *41: Does the Activity Value Assigned to these Alleles Need to be Reduced to more Accurately Predict Phenotype?	33
Clinical Evidence 2030	32
Return of Clinically Actionable Pharmacogenetic Results From Molecular Tumor Board DNA Sequencing Data: Workflow and Estimated Costs	32
Clinical and Molecular Perspectives on Inflammation‐Mediated Regulation of Drug Metabolism and Transport	32
Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after Kidney Transplantation with Population Pharmacokinetic Modeling	32
A Case for Synthetic Data in Regulatory Decision‐Making in Europe	32
In This Issue	31
Highlighted Articles	31
Issue Information	30
ASCPT News	30
The Impact of QT‐Prolonging Medications and Drug–Drug Interactions on QTc Interval Prolongation in Hospitalized Patients: A Case‐Crossover Study	30
A Retrospective Analysis of the Potential Impact of Differences in Aggregates on Clinical Immunogenicity of Biosimilars and their Reference Products	29
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer	29
Discovering Severe Adverse Reactions From Pharmacokinetic Drug–Drug Interactions Through Literature Analysis and Electronic Health Record Verification	29
Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors	29
Impact of Mercaptopurine Metabolites on Disease Outcome in the AIEOP‐BFM ALL 2009 Protocol for Acute Lymphoblastic Leukemia	29

The Future of Machine Learning Within Target Identification: Causality, Reversibility, and Druggability	29
In Memoriam Michelle A. Rudek (1972–2023)	28
Optimal Treatment Based on Interferon No Longer Makes Clinical Cure of Chronic Hepatitis B Far Away: An Evidence‐Based Review on Emerging Clinical Data	28
Development of a Translational Exposure‐Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products	28
HIV Pharmacology Data Repository: Setting the New Information‐Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies	27
Trust in the Food and Drug Administration: A National Survey Study	27
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation	27
Navigating Pharmacogenomic Testing in Practice: Who to Test and When to Test	27
Pharmacokinetic‐Pharmacodynamic Modeling of the Ponesimod Effect on Heart Rate in Patients With Multiple Sclerosis	27
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Exposure–Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma	26
New and Emerging Research on Solute Carrier and ATP Binding Cassette Transporters in Drug Discovery and Development: Outlook From the International Transporter Consortium	26
Assessing Correlation between Surrogate Endpoints and Overall Survival for Oncology Clinical Trials	26
Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT2024	26
From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology Modeling in Cancer Immunotherapy	25
ESR1 Variants and Subcontinental Genomic Ancestry: Insights from the 1000 Genomes Project and Native American Populations	25
Industry Perspective on First‐in‐Human and Clinical Pharmacology Strategies to Support Clinical Development of T‐Cell Engaging Bispecific Antibodies for Cancer Therapy	25
Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development	25
Impact of CYP2C19 Phenotype on Escitalopram Response in Geriatrics: Based on Physiologically‐Based Pharmacokinetic Modeling and Clinical Observation	25
Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program	25
ASCPT 125th Anniversary: A Society Leadership Perspective	25
Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value	24
Participants in the FDA's Biomarker Qualification Program	24
Physiologically Based Pharmacokinetic Modeling to Investigate the Disease‐Drug–Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID‐19 Patients with CYP2C19	24
Association of Parenteral Anticoagulation Therapy With Outcomes in Non–ST‐Segment Elevation Acute Coronary Syndrome Patients Without Invasive Therapy: Findings from the Improving Care for Cardiovascul	24
Drug Disposition Protein Quantification in Matched Human Jejunum and Liver From Donors With Obesity	24
Risk of Heart Failure in Rheumatoid Arthritis Patients Treated with Tumor Necrosis Factor‐α Inhibitors	24
Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective	24
Corrigendum: Translational Pharmacogenomics: Discovery, Evidence Synthesis, Delivery of Race‐Conscious Medicine	24
Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024	24
Safety and Dosing Study of a Cholecystokinin Receptor Antagonist in Non‐alcoholic Steatohepatitis	24
Regulatory Issues of Platform Trials: Learnings from EU‐PEARL	23
Model‐Informed Approach to Recommend Burosumab Dosing Regimens for Pediatric and Adult Patients With the Ultrarare Disease Tumor‐Induced Osteomalacia	23
Aging‐Related CYP3A Functional Changes in Chinese Older Patients: New Findings from Model‐Based Assessment of Amlodipine	23
Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda	23
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All	22
Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population‐Based Cohort Study	22
Thiopurine Methyltransferase Intermediate Metabolizer Status and Thiopurine‐Associated Toxicity During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia	22
Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection	21
Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites	21
Multi‐Omics Studies in Historically Excluded Populations: The Road to Equity	21
Issue Information	21
A Metabolomic Analysis of Sensitivity and Specificity of 23 Previously Proposed Biomarkers for Renal Transporter‐Mediated Drug‐Drug Interactions	21
Highlighted Articles	21
Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level	20
Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database	20
Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study	20
Issue Information	20
Is Liquid Biopsy Only Restricted to Diagnostics or Can it Go Beyond the Confines of Genotyping and Phenotyping for Quantitative Pharmacology?	20
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease	20
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Highlights	20
Model‐Informed Drug Development: Steps Toward Harmonized Guidance	20
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?	20
Highlights	20
Issue Information	19
Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5‐Year Retrospective Analysis	19
Implementation of NUDT15 Genotyping to Prevent Azathioprine‐Induced Leukopenia for Patients With Autoimmune Disorders in Chinese Population	19
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ASCPT News	19
Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology	19
A Nomogram to Predict Severe Toxicity in DPYD Wild‐Type Patients Treated With Capecitabine‐Based Anticancer Regimens	19
Pharmacogenomic Clinical Decision Support: A Scoping Review	19
Clinical Actionability of the NUDT15 *4 (p.R139H) Allele and Its Association With Hispanic Ethnicity	19
Challenges and Possible Strategies to Address Them in Rare Disease Drug Development: A Statistical Perspective	19
Optimal Drug, Optimal Dose, or Both in the Pharmacological Treatment of Neonatal Opioid Withdrawal Syndrome?	19
Ticagrelor versus Adjusted‐Dose Prasugrel in Acute Coronary Syndrome with Percutaneous Coronary Intervention	19
Development in Prescriptions of Contraindicated and Potentially Harmful QT Interval–Prolonging Drugs in a Large Geriatric Inpatient Cohort From 2011 to 2021	19
The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making	19
Changes in Protein Expression of Renal Drug Transporters and Drug‐Metabolizing Enzymes in Autosomal Dominant Polycystic Kidney Disease Patients	18
Optimizing Dosage in Pharmacotherapy—Missing the Forest for the Trees	18
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective	18
Warfarin‐Rifampin‐Gene (WARIF‐G) Interaction: A Retrospective, Genetic, Case–Control Study	18
Comparative Intra‐Subject Analysis of Gene Expression and Protein Abundance of Major and Minor Drug Metabolizing Enzymes in Healthy Human Jejunum and Liver	18
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper	18
Personalizing Direct Oral Anticoagulant Therapy for a Diverse Population: Role of Race, Kidney Function, Drug Interactions, and Pharmacogenetics	18
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions	18
Population Pharmacokinetic and Exposure–Response Analyses for Efficacy and Safety of Risankizumab in Patients With Active Crohn's Disease	18
Highlighted Articles	17
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In this Issue	17
Assessment of Efficacy Evidence for Approvals of Novel Drugs in China Between 2018 and 2022	17
ASCPT News	17
Crossing the Chasm: How to Approach Translational Pharmacokinetic–Pharmacodynamic Modeling of Phage Dosing	17
Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage Optimization for Patients with Renal Insufficiency or Receiving Continuous Renal Replacement Therapy	17
Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID‐19 Trial of Nirmatrelvir	17
Highlights	17
Issue Information	17
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Progress in Clinical Pharmacology in China: An Ongoing Evolution	16
How Much More Efficient Are Adaptive Platform Trials Than Multiple Stand‐Alone Trials? A Comprehensive Simulation Study for Streamlining Drug Development During a Pandemic	16
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics	16
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Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019	16
Development and Validation of the Pharmacological Statin‐Associated Muscle Symptoms Risk Stratification Score Using Electronic Health Record Data	16
ASCPT News	16
Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic	16
Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity	16
Prediction of Busulfan Clearance by Predose Plasma Metabolomic Profiling	15
Moving Toward a Question‐Centric Approach for Regulatory Decision Making in the Context of Drug Assessment	15
Population Pharmacokinetics of siRNA JNJ‐73763989 in Healthy Participants and Patients With Chronic Hepatitis B	15
Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology	15
A Quantitative Systems Pharmacology Model Describing the Cellular Kinetic‐Pharmacodynamic Relationship for a Live Biotherapeutic Product to Support Microbiome Drug Development	15
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical Development	15
Implementation of DPYD Genotyping in Admixed American Populations: Brazil as a Model Case	15
Immune Checkpoint Inhibitors and Venous Thromboembolism: An Analysis of the WHO Pharmacovigilance Database	15
ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs	15
How to Run the Pharmacogenomics Clinical Annotation Tool (PharmCAT)	15
PBPK Modeling of Entrectinib and Its Active Metabolite to Derive Dose Adjustments in Pediatric Populations Co‐Administered with CYP3A4 Inhibitors	15
Prescriber Adoption of SLCO1B1Genotype‐Guided Simvastatin Clinical Decision Support in a Clinical Pharmacogenetics Program	15
Tacrolimus and Mycophenolic Acid Exposure Are Associated with Biopsy‐Proven Acute Rejection: A Study to Provide Evidence for Longer‐Term Target Ranges	15
Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After Nephrotoxic and Ischemic Injury	15
The Pandemic as a Catalyst for Disruptive Innovation in Clinical Pharmacology	14
Psychedelics and Psychotherapy: Is the Whole Greater than the Sum of its Parts?	14
TMS and EEG Pharmacodynamic Effects of a Selective Sphingosine‐1‐Phosphate Subtype 1 Receptor Agonist on Cortical Excitability in Healthy Subjects	14
Pharmacokinetics of Intravenous Paracetamol (Acetaminophen) and Ductus Arteriosus Closure After Premature Birth	14
Keyword Index	14
Precision Reimbursement for Precision Medicine: Using Real‐World Evidence to Evolve From Trial‐and‐Project to Track‐and‐Pay to Learn‐and‐Predict	14
Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan	14
Investigational Use of Real‐World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma From the Randomized Phase Ib/II MORPHEUS Trial	14
Issue Information	14
ASCPT News	14
Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft‐Versus‐Host Disease	14
Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo‐controlled Trial in Constipation	14
Populations Addressed in Vaccines Approved via the European Medicines Agency	14
Pharmacokinetic Enhancement of Elexacaftor/Tezacaftor/Ivacaftor for Cystic Fibrosis: A Cost Reduction Strategy to Address Global Disparities in Access	14
Ziritaxestat Drug–Drug Interaction with Oral Contraceptives: Role of SULT1E1 Inhibition	14
Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer	14
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Quantitative Systems Toxicology Modeling Informed Safe Dose Selection of Emvododstat in Acute Myeloid Leukemia Patients	14
The Role of Pharmacogenetics in Smoking	14
FDA Breakthrough Therapy Designation–Trial Design and More – Commentary	14
A Multistakeholder Perspective on Advancing Individualized Therapeutics	14
Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group‐Pediatr	14
Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With Concomitant Rifampicin: A Dose Escalation Study	14
A Comparative Clinical Pharmacology Analysis of FDA‐Approved Targeted Covalent Inhibitors vs. Reversible Inhibitors in Oncology	14
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	13
Physiologically Based Pharmacokinetic Modeling to Determine the Impact of CYP2B6 Genotype on Efavirenz Exposure in Children, Mothers and Breastfeeding Infants	13
A Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Insulin Dimer	13
Promoting Pharmacogenomics in Africa: Perspectives From Variation in G6PD and Other Pharmacogenes	13
Role of Cytochrome P450 2C8 in Drug–Drug Interaction between Amiodarone and Nirmatrelvir/Ritonavir Via Physiologically‐Based Pharmacokinetic Modeling	13
Folinic Acid Prophylaxis and Dose Adjustments Enable Safe Treatment with Pemetrexed in Patients with Renal Impairment	13
Drug Interactions Brewing	13
Impact of the ABCD‐GENE Score on Clopidogrel Clinical Effectiveness after PCI: A Multi‐Site, Real‐World Investigation	13
COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study	13
Mitigating Drug–Target–Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors	13
Population Pharmacokinetics and Exposure–Response Analysis for the CTLA‐4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study	13
Japan's Conditional/Time‐Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets	13
Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations	13
Model‐Informed Precision Dosing Using Machine Learning for Levothyroxine in General Practice: Development, Validation and Clinical Simulation Trial	13
Clinical Pharmacogenomic MT‐RNR1 Screening for Aminoglycoside‐Induced Ototoxicity and the Post‐Test Counseling Conundrum	13
Dose Titration of Ixazomib Maintenance Therapy in Transplant‐Ineligible Multiple Myeloma: Exposure–Response Analysis of the TOURMALINE‐MM4 Study	13
Successes and Opportunities during the Pandemic: Reflections and Revelations from a Vaccine Development Perspective	13
Issue Information	12
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Translational Modeling as a Tool to Evaluate the Effectiveness of Nalmefene in a Community Setting: A Critical Perspective	12
Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase	12
Safety Profile of Eltrombopag in Different Age Groups: An Analysis of Real‐World Pharmacovigilance and Randomized Clinical Trials	12
A Systematic Review of the Costs of Drug‐Associated Acute Kidney Injury and Potential Cost Savings With Nephrotoxin Stewardship Prevention Strategies	12
Highlights	12
Regulator‐Requested Non‐Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review	12
Mapping the miRNA‐mRNA Interactome in Human Hepatocytes and Identification of Functional mirSNPs in Pharmacogenes	12
Effect of the Proton Pump Inhibitor Esomeprazole on the Systemic Exposure of Capecitabine: Results of A Randomized Crossover Trial	12
The Changing Landscape for Human Absorption, Metabolism, and Excretion: Practical Experiences From a Data Analysis of 500 Studies	12
Current Perspectives on Data Sharing and Open Science in Pharmacogenomics	12
Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction	12
Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Studies Related to Vincristine‐Induced Peripheral Neuropathy in Chinese Pediatric ALL Patients	12
Issue Information	12
Polygenic Risk Scores for Blood Pressure to Assess the Risk of Severe Bevacizumab‐Induced Hypertension in Cancer Patients (Alliance)	12
ASCPT NEWS	12
Features of Inflammatory Heart Reactions Following mRNA COVID‐19 Vaccination at a Global Level	12
Dose Adjustment in Patients with Liver Cirrhosis – Comparison of Two Different Modeling Approaches	12
Local Ancestry‐Informed Candidate Pathway Analysis of Warfarin Stable Dose in Latino Populations	12
Effects of Genetic Polymorphisms of Drug Metabolizing Enzymes and co‐Medications on Tamoxifen Metabolism in Black South African Women with Breast Cancer	12