Clinical Pharmacology & Therapeutics

Article	Citations
Issue Information	383
Return to SENDer: The Submitted Electronic Data for Nonclinical Cardiovascular Studies is Not Facilitating Transparency, Translation or Innovation	236
Exploring the Association Between Intra‐Patient Variability in Trough Concentration of Pazopanib and Clinical Outcomes in Renal Cell Carcinoma and Soft Tissue Sarcoma Patients	157
In this Issue	112
	95
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An IQ Perspective	87
The Broader Context of Liquid Biopsy in Absorption, Distribution, Metabolism, and Elimination	74
FDA Adverse Event Reporting System Essentials: A Reflection on Study Conception	74
Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype‐Guided Precision Medicine	72
Reply to “Interpretation of Pharmacovigilance Disproportionality Analyses”	71
Reply to “Questioning Bayesian Inference‐Based Models for Estimating Culprit Drugs for Adverse Drug Reactions”	66
Model‐Informed Selection of the Recommended Phase 2 Dosage for Anti‐TIGIT Immunotherapy Leveraging co‐Expressed PD‐1 Inhibitor Target Engagement	65
Integrated Evidence Planning for Enhancing Patient Care: Harnessing the Power of Real‐World Evidence	64
Liquid Biopsies or Therapeutic Drug Monitoring for CYP Activity Profile Determination	63
Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs	62
Pharmacogenomic Prescribing Guidelines: Are They Always Useful?	61
Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy Volunteers and Patients with Chronic Kidney Disease	60
The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities	59
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives	56
Machine Learning‐Led Optimization of Combination Therapy: Confronting the Public Health Threat of Extensively Drug Resistant Gram‐Negative Bacteria	55
Protecting the Kidney: The Unexpected Logic of Inhibiting a Glucose Transporter	54
A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization	53
Promise of Quantitative Proteomics in the Qualification of New Approach Methodologies	52
Repeated Intake of Grapefruit Juice Inhibits CYP2B6 , CYP2C9 , CYP2C19	51
Advances in Clinical Therapies for Huntington's Disease and the Promise of Multi‐Targeted/Functional Drugs Based on Clinicaltrials.gov	50

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	48
Comprehensive Evaluation of OATP‐ and BCRP‐Mediated Drug–Drug Interactions of Methotrexate Using Physiologically‐Based Pharmacokinetic Modeling	45
Infection Risk Associated with High‐Efficacy Disease‐Modifying Agents in Multiple Sclerosis: A Retrospective Cohort Study	44
More Than Pharmacokinetics: Transporters in Clinical Pharmacology	43
Factors Influencing Medication Adherence in Heart Failure Patients—A Survey Among Cardiac Healthcare Providers	41
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID‐19 Under the Emergency Use Authorization	40
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	40
Denosumab Offers Relatively Lower Initial Protection Against Osteoporotic Vertebral Fractures in Treatment‐Naive Patients Compared With Zoledronate	39
Why Pediatric CAR ‐T Therapies Still Lag Behind: Insights from Six Treatments Centrally Approved in Europe	38
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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	37
Frequency of Key Pharmacogenes CYP2C9 , CYP2C19 , CYP2D6	37
Estimating Culprit Drugs for Adverse Drug Reactions Based on Bayesian Inference	36
Nicotine Metabolite Ratio Decreases After Switching Off Efavirenz‐Based Therapy in People With HIV Who Smoke	36
Development of Therapeutic Proteins for a New Subcutaneous Route of Administration After the Establishment of Intravenous Dosages: A Systematic Review	34
Repurposing Acebutolol for Osteoporosis Treatment: Insights From Multi‐Omics and Multi‐Modal Data Analysis	34
Chinese Expert Consensus on the Clinical Diagnosis and Management of Statin Intolerance	33
Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency	33
Building Pharmacoequity through Student and Trainee Education, Service, and Global Outreach	33
Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned	32
Requirements for Phase Lag in First‐In‐Human Trials in India: Proceedings of a Panel Discussion	32
Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers	32
French‐Speaking Network of Pharmacogenetics (RNPGx) Recommendations for Clinical Use of Mavacamten	31
A Guide for Implementing DPYD Genotyping for Systemic Fluoropyrimidines into Clinical Practice	31
Highlights	31
ASCPT News	31
Issue Information	30
ASCPT News	30
In This Issue	30
ASCPT News	30
From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology Modeling in Cancer Immunotherapy	29
ASCPT 125th Anniversary: A Society Leadership Perspective	29
In Memoriam Michelle A. Rudek (1972–2023)	29
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Highlighted Articles	29
A Case for Synthetic Data in Regulatory Decision‐Making in Europe	28
ESR1 Variants and Subcontinental Genomic Ancestry: Insights from the 1000 Genomes Project and Native American Populations	28
In this Issue	28
ASCPT News	27
Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT2024	26
Return of Clinically Actionable Pharmacogenetic Results From Molecular Tumor Board DNA Sequencing Data: Workflow and Estimated Costs	26
Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program	25
Development of a Translational Exposure‐Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products	25
Impact of CYP2C19 Phenotype on Escitalopram Response in Geriatrics: Based on Physiologically‐Based Pharmacokinetic Modeling and Clinical Observation	25
Pharmacokinetic‐Pharmacodynamic Modeling of the Ponesimod Effect on Heart Rate in Patients With Multiple Sclerosis	25
The Impact of QT‐Prolonging Medications and Drug–Drug Interactions on QTc Interval Prolongation in Hospitalized Patients: A Case‐Crossover Study	25
HIGHLIGHTED ARTICLES	25
PharmVar GeneFocus : NAT2 — Genetic Variation	24

HIV Pharmacology Data Repository: Setting the New Information‐Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies	24
A Retrospective Analysis of the Potential Impact of Differences in Aggregates on Clinical Immunogenicity of Biosimilars and their Reference Products	24
Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after Kidney Transplantation with Population Pharmacokinetic Modeling	24
More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations	24
The Future of Machine Learning Within Target Identification: Causality, Reversibility, and Druggability	24
Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors	24
Trust in the Food and Drug Administration: A National Survey Study	23
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer	23
Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma Companies	23
Discovering Severe Adverse Reactions From Pharmacokinetic Drug–Drug Interactions Through Literature Analysis and Electronic Health Record Verification	23
Impact of Mercaptopurine Metabolites on Disease Outcome in the AIEOP‐BFM ALL 2009 Protocol for Acute Lymphoblastic Leukemia	23
Effect of Late Second to Early Third Trimester of Pregnancy on the Activity of Renal Organic Anion Transporters (OAT1 and OAT3): A Biomarker Study	23
Clinical Evidence 2030	23
Issue Information	22
Navigating Pharmacogenomic Testing in Practice: Who to Test and When to Test	22
Optimal Treatment Based on Interferon No Longer Makes Clinical Cure of Chronic Hepatitis B Far Away: An Evidence‐Based Review on Emerging Clinical Data	22
Assessing Correlation between Surrogate Endpoints and Overall Survival for Oncology Clinical Trials	22
Piperacillin Population Pharmacokinetics in Plasma and Peritoneal Fluid and Dosing Optimization in Children Undergoing Liver Transplant: An Optimome Study	22
Industry Perspective on First‐in‐Human and Clinical Pharmacology Strategies to Support Clinical Development of T‐Cell Engaging Bispecific Antibodies for Cancer Therapy	22
Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development	22
Issue Information	21
Model‐Informed Drug Development: Steps Toward Harmonized Guidance	21
Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites	21
Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda	21
Biomarker Utilization for Regulatory Decision Making: A Landscape Analysis of Neurological Drug Products Approved by FDA (2008–2024)	21
Carbon Footprint of Antibody‐Based Drugs and Biologics Using Hybrid Life Cycle Assessment	21
Model‐Informed Approach to Recommend Burosumab Dosing Regimens for Pediatric and Adult Patients With the Ultrarare Disease Tumor‐Induced Osteomalacia	21
Model‐Informed Drug Development Supports Full Approval of Ibuprofen Injection in Chinese Pediatric Patients With Fever or Pain	21
Pathway‐Informed Machine Learning Identifies Genetic Predictors of High‐Dose Methotrexate‐Induced Mucositis in Pediatric Acute Lymphoblastic Leukemia	21
Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024	21
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation	21
Is Liquid Biopsy Only Restricted to Diagnostics or Can it Go Beyond the Confines of Genotyping and Phenotyping for Quantitative Pharmacology?	20
Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection	20
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All	20
Highlighted Articles	20
Safety and Dosing Study of a Cholecystokinin Receptor Antagonist in Non‐alcoholic Steatohepatitis	19
Thiopurine Methyltransferase Intermediate Metabolizer Status and Thiopurine‐Associated Toxicity During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia	19
A Metabolomic Analysis of Sensitivity and Specificity of 23 Previously Proposed Biomarkers for Renal Transporter‐Mediated Drug‐Drug Interactions	19
Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level	19
Regulatory Issues of Platform Trials: Learnings from EU‐PEARL	19
Participants in the FDA's Biomarker Qualification Program	19
Emulating Comparative Oncology Trials With Real‐World Evidence Studies ( ENCORE ): Process Development and Methodological Considerations for Oncology	19
Physiologically Based Pharmacokinetic Modeling to Investigate the Disease‐Drug–Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID‐19 Patients with CYP2C19	19
Aging‐Related CYP3A Functional Changes in Chinese Older Patients: New Findings from Model‐Based Assessment of Amlodipine	19
Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population‐Based Cohort Study	18
Clinical and Quantitative Pharmacology Considerations of mRNA Therapeutics and Vaccine Development: Bridging Translational and Platform Gaps for Enha	18
Progress in Pharmacogenomics Implementation in the United States: Barrier Erosion and Remaining Challenges	18
Issue Information	18
Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective	18
Multi‐Omics Studies in Historically Excluded Populations: The Road to Equity	18
Ocular Complications of SGLT ‐2 Inhibitors, GLP ‐1 Receptor Agonists, and	18
Highlights	18
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease	18
Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database	18
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The Type of Follicle‐Stimulating Hormone Medication Given for In Vitro Fertilization Impacts Oocyte Retrieval: A Systematic Review and Meta‐Analysis	17
ASCPT News	17
Changes in Protein Expression of Renal Drug Transporters and Drug‐Metabolizing Enzymes in Autosomal Dominant Polycystic Kidney Disease Patients	17
Optimizing Dosage in Pharmacotherapy—Missing the Forest for the Trees	17
Revisiting Tirzepatide’s Body Composition Model: Underestimated Fat‐Free Mass Loss and Clinical Implications	17
Optimal Drug, Optimal Dose, or Both in the Pharmacological Treatment of Neonatal Opioid Withdrawal Syndrome?	17
Abstracts	17
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper	17
Pharmacogenomic Clinical Decision Support: A Scoping Review	17
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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	17
Issue Information	17
Development in Prescriptions of Contraindicated and Potentially Harmful QT Interval–Prolonging Drugs in a Large Geriatric Inpatient Cohort From 2011 to 2021	16
An Evaluation of the Drug Interaction Potential of Encorafenib in Combination With Binimetinib Using the Inje Cocktail in Patients With Cancer	16
Ticagrelor versus Adjusted‐Dose Prasugrel in Acute Coronary Syndrome with Percutaneous Coronary Intervention	16
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions	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
Assessment of Efficacy Evidence for Approvals of Novel Drugs in China Between 2018 and 2022	16
Personalizing Direct Oral Anticoagulant Therapy for a Diverse Population: Role of Race, Kidney Function, Drug Interactions, and Pharmacogenetics	16
Clinical Actionability of the NUDT15 *4 (p.R139H) Allele and Its Association With Hispanic Ethnicity	16
Real‐World Edoxaban Concentrations in Older Patients Receiving Reduced‐Dose Regimens	16
Warfarin‐Rifampin‐Gene (WARIF‐G) Interaction: A Retrospective, Genetic, Case–Control Study	16
Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?	16
Implementation of NUDT15 Genotyping to Prevent Azathioprine‐Induced Leukopenia for Patients With Autoimmune Disorders in Chinese Population	15
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ASCPT News	15
Model‐Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated	15
Challenges and Possible Strategies to Address Them in Rare Disease Drug Development: A Statistical Perspective	15
The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making	15
Highlighted Articles	15
Issue Information	15
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical Development	15
Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology	15
Population Pharmacokinetic and Exposure–Response Analyses for Efficacy and Safety of Risankizumab in Patients With Active Crohn's Disease	15
Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5‐Year Retrospective Analysis	15
In this Issue	15
Highlights	15
ASCPT News	15
A Nomogram to Predict Severe Toxicity in DPYD Wild‐Type Patients Treated With Capecitabine‐Based Anticancer Regimens	15
In This Issue	14
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics	14
Population Pharmacokinetics of Intravenous Methadone Enantiomers in Adults: A Comprehensive Model	14
Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After Nephrotoxic and Ischemic Injury	14
Development and Validation of the Pharmacological Statin‐Associated Muscle Symptoms Risk Stratification Score Using Electronic Health Record Data	14
Quantitative Systems Toxicology Predicts Ivacaftor‐Induced Oxidative Stress Contributes to CFTR Modulator Hepatotoxicity	14
Progress in Clinical Pharmacology in China: An Ongoing Evolution	14
Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity	14
A Quantitative Systems Pharmacology Model Describing the Cellular Kinetic‐Pharmacodynamic Relationship for a Live Biotherapeutic Product to Support Microbiome Drug Development	14
Response to “Misuse of the Term Biorhythms Undermines Chronological Research”	14
Prescriber Adoption of SLCO1B1Genotype‐Guided Simvastatin Clinical Decision Support in a Clinical Pharmacogenetics Program	14
Guided Sample Pooling in Human Mass Balance Studies: A Recommended Strategic Decision Framework	14
Implementation of DPYD Genotyping in Admixed American Populations: Brazil as a Model Case	14
Is a Clinical Trial With a Non‐Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK	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	13
Prognostic Implication of CYP2C19 Genotype According to Clinical Risk Stratification After Drug‐Eluting Stent Implantation	13
A Comment about AI Methods that May Help Advance Pharmacovigilance	13
Population Pharmacokinetic Modeling of Glycochenodeoxycholic Acid 3‐O‐Sulfate ( GCDCA ‐S) as Endogenous Biomarker of OATP1B3	13
Quantitative Systems Toxicology Modeling Informed Safe Dose Selection of Emvododstat in Acute Myeloid Leukemia Patients	13
Advancing Maternal Health with Long‐Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging Technologies	13
Tacrolimus and Mycophenolic Acid Exposure Are Associated with Biopsy‐Proven Acute Rejection: A Study to Provide Evidence for Longer‐Term Target Ranges	13
Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage Optimization for Patients with Renal Insufficiency or Receiving Continuous Renal Replacement Therapy	13
American Society for Clinical Pharmacology and Therapeutics	13
Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo‐controlled Trial in Constipation	13
Moving Toward a Question‐Centric Approach for Regulatory Decision Making in the Context of Drug Assessment	13
Population Pharmacokinetics of siRNA JNJ ‐73763989 in Healthy Participants and Patients With Chronic Hepatitis B	13
How to Run the Pharmacogenomics Clinical Annotation Tool (PharmCAT)	13
Crossing the Chasm: How to Approach Translational Pharmacokinetic–Pharmacodynamic Modeling of Phage Dosing	13
Biomarkers of Drug‐Induced Kidney Injury: Use in Clinical Trials and Recent Examples of Impact on Drug Development	13
In This Issue	13
Population Pharmacokinetic and Exposure‐Efficacy Analysis of Baloxavir Marboxil for Influenza Treatment and Post‐Exposure Prophylaxis in Children	13
Prediction of Busulfan Clearance by Predose Plasma Metabolomic Profiling	13
PBPK Modeling of Entrectinib and Its Active Metabolite to Derive Dose Adjustments in Pediatric Populations Co‐Administered with CYP3A4 Inhibitors	13
Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology	13
A Comparison of Regional Decisions for Doses and Administrations of New Drugs: Concordance, Discordance, and Dependencies	13
Real‐World Safety of JAK Inhibitors in Skin Immune‐Mediated Inflammatory Diseases: Boxed Warning Outcomes from a Multinational Cohort Study	13
Mitigating Drug–Target–Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors	12
A Multistakeholder Perspective on Advancing Individualized Therapeutics	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
Emerging Tools and Technologies for Microbiome‐Aware Drug Development	12
Drug Interactions Brewing	12
COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study	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
Folinic Acid Prophylaxis and Dose Adjustments Enable Safe Treatment with Pemetrexed in Patients with Renal Impairment	12
Keyword Index	12
Promoting Pharmacogenomics in Africa: Perspectives From Variation in G6PD and Other Pharmacogenes	12
Population Pharmacokinetics and Exposure–Response Analysis for the CTLA‐4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study	12
Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer	12
Challenging the Detection of Comedication Interactions Related to Immune‐Related Adverse Events Using Spontaneous Reporting Systems	12
Model‐Informed Precision Dosing Using Machine Learning for Levothyroxine in General Practice: Development, Validation and Clinical Simulation Trial	12
Successes and Opportunities during the Pandemic: Reflections and Revelations from a Vaccine Development Perspective	12
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Clinical Pharmacogenomic MT‐RNR1 Screening for Aminoglycoside‐Induced Ototoxicity and the Post‐Test Counseling Conundrum	12
Risk of Acute Kidney Injury Associated With Nephrotoxic Burden in Hospitalized Patients: A Scoping Review	12
Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With Concomitant Rifampicin: A Dose Escalation Study	12
Pharmacokinetic Enhancement of Elexacaftor/Tezacaftor/Ivacaftor for Cystic Fibrosis: A Cost Reduction Strategy to Address Global Disparities in Access	12
In this Issue	12
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Role of Cytochrome P450 2C8 in Drug–Drug Interaction between Amiodarone and Nirmatrelvir/Ritonavir Via Physiologically‐Based Pharmacokinetic Modeling	12
ASCPT News	12
Issue Information	12
TMS and EEG Pharmacodynamic Effects of a Selective Sphingosine‐1‐Phosphate Subtype 1 Receptor Agonist on Cortical Excitability in Healthy Subjects	11
ASCPT NEWS	11
Coproporphyrin I as an Endogenous Biomarker to Detect Reduced OATP1B Activity and Shift in Elimination Route in Chronic Kidney Disease	11
Highlights	11
From Classical PKPD to Model‐Informed Drug Development: Are “Digital Twins” a New Paradigm?	11
Post‐Approval Pediatric Use of Drugs Granted Waivers from Pediatric Testing	11
Populations Addressed in Vaccines Approved via the European Medicines Agency	11
Use of FDA Expedited Programs and Development Timelines for New Molecular Entity Drug and New Biologic Approvals by Sponsor Experience	11
Causal Effects of Hydrophilic Bile Acids on Carfilzomib‐Related Cardiovascular Events in Multiple Myeloma: A Mendelian Randomization Study	11
Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase	11
Issue Information	11
Community Partnerships in Clinical Research: A Framework for Sustainability and Resilience	11
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Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group‐Pediatr	11
Japan's Conditional/Time‐Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets	11
Investigational Use of Real‐World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma From the Randomized Phase Ib/II MORPHEUS Trial	11
Issue Information	11
Translational Modeling as a Tool to Evaluate the Effectiveness of Nalmefene in a Community Setting: A Critical Perspective	11
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibit	11