OOIR: Observatory of International Research

Papers

(The median citation count of Clinical Pharmacology & Therapeutics is 2. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2022-01-01 to 2026-01-01.)

Article	Citations
Issue Information	366
Return to SENDer: The Submitted Electronic Data for Nonclinical Cardiovascular Studies is Not Facilitating Transparency, Translation or Innovation	289
Exploring the Association Between Intra‐Patient Variability in Trough Concentration of Pazopanib and Clinical Outcomes in Renal Cell Carcinoma and Soft Tissue Sarcoma Patients	272
Machine Learning‐Led Optimization of Combination Therapy: Confronting the Public Health Threat of Extensively Drug Resistant Gram‐Negative Bacteria	227
In this Issue	132
ASCPT News	114
In This Issue	100
Estimating Culprit Drugs for Adverse Drug Reactions Based on Bayesian Inference	92
	85
French‐Speaking Network of Pharmacogenetics (RNPGx) Recommendations for Clinical Use of Mavacamten	81
FDA Adverse Event Reporting System Essentials: A Reflection on Study Conception	65
Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy Volunteers and Patients with Chronic Kidney Disease	64
Comprehensive Evaluation of OATP‐ and BCRP‐Mediated Drug–Drug Interactions of Methotrexate Using Physiologically‐Based Pharmacokinetic Modeling	63
A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization	63
US Food and Drug Administration's Advancing Real‐World Evidence Program: Initial Experience	57
Nicotine Metabolite Ratio Decreases After Switching Off Efavirenz‐Based Therapy in People With HIV Who Smoke	56
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An IQ Perspective	55
Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency	55
The Broader Context of Liquid Biopsy in Absorption, Distribution, Metabolism, and Elimination	51
Longitudinal Model‐Based Meta‐Analysis of Lung Function Response to Support Phase III Study Design in Chinese Patients With Asthma	51
Neurodegenerative Diseases: The Value of Early Predictive End Points	51
Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype‐Guided Precision Medicine	50
Protecting the Kidney: The Unexpected Logic of Inhibiting a Glucose Transporter	49
Reply to “Interpretation of Pharmacovigilance Disproportionality Analyses”	47
Integrated Evidence Planning for Enhancing Patient Care: Harnessing the Power of Real‐World Evidence	46

Model‐Informed Selection of the Recommended Phase 2 Dosage for Anti‐TIGIT Immunotherapy Leveraging co‐Expressed PD‐1 Inhibitor Target Engagement	46
Reply to “Questioning Bayesian Inference‐Based Models for Estimating Culprit Drugs for Adverse Drug Reactions”	46
Model‐Based Prediction of Irinotecan‐Induced Grade 4 Neutropenia in Advanced Cancer Patients: Influence of Demographic and Clinical Factors	45
Liquid Biopsies or Therapeutic Drug Monitoring for CYP Activity Profile Determination	44
How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example	43
Drug‐Induced QT Prolongation: Associations Between Risk Classifications in a Swedish Clinical Decision Support System and Clinical Outcomes	42
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives	41
Promise of Quantitative Proteomics in the Qualification of New Approach Methodologies	40
The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities	40
More Than Pharmacokinetics: Transporters in Clinical Pharmacology	38
Repurposing Acebutolol for Osteoporosis Treatment: Insights From Multi‐Omics and Multi‐Modal Data Analysis	38
Repeated Intake of Grapefruit Juice Inhibits CYP2B6 , CYP2C9 , CYP2C19	36
Development of Therapeutic Proteins for a New Subcutaneous Route of Administration After the Establishment of Intravenous Dosages: A Systematic Review	36
Factors Influencing Medication Adherence in Heart Failure Patients—A Survey Among Cardiac Healthcare Providers	36
Effect of CYP3A5 and CYP3A4 Genetic Variants on Fentanyl Pharmacokinetics in a Pediatric Population	36
Predicting Survival in Patients with Advanced NSCLC Treated with Atezolizumab Using Pre‐ and on‐Treatment Prognostic Biomarkers	36
A Biological Basis for Pharmacokinetics: The Remote Sensing and Signaling Theory	35
Using Machine Learning to Individualize Treatment Effect Estimation: Challenges and Opportunities	35
Advances in Clinical Therapies for Huntington's Disease and the Promise of Multi‐Targeted/Functional Drugs Based on Clinicaltrials.gov	35
Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs	35
Chinese Expert Consensus on the Clinical Diagnosis and Management of Statin Intolerance	34
PharmVar GeneFocus: CYP3A5	33
Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers	33
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID‐19 Under the Emergency Use Authorization	33
A Guide for Implementing DPYD Genotyping for Systemic Fluoropyrimidines into Clinical Practice	33
Infection Risk Associated with High‐Efficacy Disease‐Modifying Agents in Multiple Sclerosis: A Retrospective Cohort Study	32
ICH S7B In Vitro Assays Do Not Address Mechanisms of QT_C Prolongation for Peptides and Proteins – Data in Support of Not Needing Dedicated QT_C Studies	32
	32
Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned	32
ASCPT News	32
Pharmacogenomic Prescribing Guidelines: Are They Always Useful?	32
Highlights	31
ASCPT News	30
Issue Information	30
ASCPT News	30
In This Issue	30
In Memoriam Michelle A. Rudek (1972–2023)	29
Assessing Correlation between Surrogate Endpoints and Overall Survival for Oncology Clinical Trials	29
Highlighted Articles	29
	29
ASCPT 125th Anniversary: A Society Leadership Perspective	29
The Impact of QT‐Prolonging Medications and Drug–Drug Interactions on QTc Interval Prolongation in Hospitalized Patients: A Case‐Crossover Study	28
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation	28
In this Issue	27
Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program	27
ESR1 Variants and Subcontinental Genomic Ancestry: Insights from the 1000 Genomes Project and Native American Populations	27
PharmVar GeneFocus : NAT2 — Genetic Variation	27
HIGHLIGHTED ARTICLES	26
Pharmacokinetic‐Pharmacodynamic Modeling of the Ponesimod Effect on Heart Rate in Patients With Multiple Sclerosis	26
Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT2024	26

ASCPT News	26
Return of Clinically Actionable Pharmacogenetic Results From Molecular Tumor Board DNA Sequencing Data: Workflow and Estimated Costs	26
The Future of Machine Learning Within Target Identification: Causality, Reversibility, and Druggability	25
Discovering Severe Adverse Reactions From Pharmacokinetic Drug–Drug Interactions Through Literature Analysis and Electronic Health Record Verification	25
A Case for Synthetic Data in Regulatory Decision‐Making in Europe	25
HIV Pharmacology Data Repository: Setting the New Information‐Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies	25
Impact of CYP2C19 Phenotype on Escitalopram Response in Geriatrics: Based on Physiologically‐Based Pharmacokinetic Modeling and Clinical Observation	25
Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors	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
Drug Loss in Japan: A Comparative Analysis with Europe for New Drugs Developed by Emerging Biopharma Companies	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
Development of a Translational Exposure‐Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products	24
A Retrospective Analysis of the Potential Impact of Differences in Aggregates on Clinical Immunogenicity of Biosimilars and their Reference Products	23
Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after Kidney Transplantation with Population Pharmacokinetic Modeling	23
Impact of Mercaptopurine Metabolites on Disease Outcome in the AIEOP‐BFM ALL 2009 Protocol for Acute Lymphoblastic Leukemia	23
Optimal Treatment Based on Interferon No Longer Makes Clinical Cure of Chronic Hepatitis B Far Away: An Evidence‐Based Review on Emerging Clinical Data	23
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer	22
Trust in the Food and Drug Administration: A National Survey Study	22
Navigating Pharmacogenomic Testing in Practice: Who to Test and When to Test	22
From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology Modeling in Cancer Immunotherapy	22
Highlighted Articles	21
Issue Information	21
Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development	21
Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective	21
Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–2024	21
Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population‐Based Cohort Study	21
Clinical Evidence 2030	21
Thiopurine Methyltransferase Intermediate Metabolizer Status and Thiopurine‐Associated Toxicity During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia	21
Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda	21
Model‐Informed Approach to Recommend Burosumab Dosing Regimens for Pediatric and Adult Patients With the Ultrarare Disease Tumor‐Induced Osteomalacia	21
Safety and Dosing Study of a Cholecystokinin Receptor Antagonist in Non‐alcoholic Steatohepatitis	20
Clinical and Quantitative Pharmacology Considerations of mRNA Therapeutics and Vaccine Development: Bridging Translational and Platform Gaps for Enha	20
Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database	20
Regulatory Issues of Platform Trials: Learnings from EU‐PEARL	20
Multi‐Omics Studies in Historically Excluded Populations: The Road to Equity	20
Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level	20
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All	20
Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection	20
Physiologically Based Pharmacokinetic Modeling to Investigate the Disease‐Drug–Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID‐19 Patients with CYP2C19	20
Biomarker Utilization for Regulatory Decision Making: A Landscape Analysis of Neurological Drug Products Approved by FDA (2008–2024)	20
Progress in Pharmacogenomics Implementation in the United States: Barrier Erosion and Remaining Challenges	19
Pathway‐Informed Machine Learning Identifies Genetic Predictors of High‐Dose Methotrexate‐Induced Mucositis in Pediatric Acute Lymphoblastic Leukemia	19
Model‐Informed Drug Development Supports Full Approval of Ibuprofen Injection in Chinese Pediatric Patients With Fever or Pain	19
Is Liquid Biopsy Only Restricted to Diagnostics or Can it Go Beyond the Confines of Genotyping and Phenotyping for Quantitative Pharmacology?	19
A Metabolomic Analysis of Sensitivity and Specificity of 23 Previously Proposed Biomarkers for Renal Transporter‐Mediated Drug‐Drug Interactions	18
Participants in the FDA's Biomarker Qualification Program	18
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease	18
	18
	18
Model‐Informed Drug Development: Steps Toward Harmonized Guidance	18
Ocular Complications of SGLT ‐2 Inhibitors, GLP ‐1 Receptor Agonists, and	18
Issue Information	18
The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making	18
Aging‐Related CYP3A Functional Changes in Chinese Older Patients: New Findings from Model‐Based Assessment of Amlodipine	18
Drug Disposition Protein Quantification in Matched Human Jejunum and Liver From Donors With Obesity	18
Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites	18
Highlights	18
ASCPT News	18
Optimal Drug, Optimal Dose, or Both in the Pharmacological Treatment of Neonatal Opioid Withdrawal Syndrome?	17
Changes in Protein Expression of Renal Drug Transporters and Drug‐Metabolizing Enzymes in Autosomal Dominant Polycystic Kidney Disease Patients	17
Issue Information	17
Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5‐Year Retrospective Analysis	17
Optimizing Dosage in Pharmacotherapy—Missing the Forest for the Trees	17
Abstracts	17
Warfarin‐Rifampin‐Gene (WARIF‐G) Interaction: A Retrospective, Genetic, Case–Control Study	17
Development in Prescriptions of Contraindicated and Potentially Harmful QT Interval–Prolonging Drugs in a Large Geriatric Inpatient Cohort From 2011 to 2021	17
Clinical Actionability of the NUDT15 *4 (p.R139H) Allele and Its Association With Hispanic Ethnicity	17
The Type of Follicle‐Stimulating Hormone Medication Given for In Vitro Fertilization Impacts Oocyte Retrieval: A Systematic Review and Meta‐Analysis	16
Ticagrelor versus Adjusted‐Dose Prasugrel in Acute Coronary Syndrome with Percutaneous Coronary Intervention	16
An Evaluation of the Drug Interaction Potential of Encorafenib in Combination With Binimetinib Using the Inje Cocktail in Patients With Cancer	16
Implementation of NUDT15 Genotyping to Prevent Azathioprine‐Induced Leukopenia for Patients With Autoimmune Disorders in Chinese Population	16
Revisiting Tirzepatide’s Body Composition Model: Underestimated Fat‐Free Mass Loss and Clinical Implications	16
Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?	16
Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study	16
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective	16
Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology	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
A Nomogram to Predict Severe Toxicity in DPYD Wild‐Type Patients Treated With Capecitabine‐Based Anticancer Regimens	16
Real‐World Edoxaban Concentrations in Older Patients Receiving Reduced‐Dose Regimens	16
Challenges and Possible Strategies to Address Them in Rare Disease Drug Development: A Statistical Perspective	16

Personalizing Direct Oral Anticoagulant Therapy for a Diverse Population: Role of Race, Kidney Function, Drug Interactions, and Pharmacogenetics	15
Pharmacogenomic Clinical Decision Support: A Scoping Review	15
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper	15
Population Pharmacokinetic and Exposure–Response Analyses for Efficacy and Safety of Risankizumab in Patients With Active Crohn's Disease	15
Assessment of Efficacy Evidence for Approvals of Novel Drugs in China Between 2018 and 2022	15
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions	15
Comparative Intra‐Subject Analysis of Gene Expression and Protein Abundance of Major and Minor Drug Metabolizing Enzymes in Healthy Human Jejunum and Liver	15
Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID‐19 Trial of Nirmatrelvir	15
	14
	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
ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs	14
ASCPT News	14
Issue Information	14
Prediction of Busulfan Clearance by Predose Plasma Metabolomic Profiling	14
Highlights	14
Development and Validation of the Pharmacological Statin‐Associated Muscle Symptoms Risk Stratification Score Using Electronic Health Record Data	14
In this Issue	14
ASCPT News	14
Tacrolimus and Mycophenolic Acid Exposure Are Associated with Biopsy‐Proven Acute Rejection: A Study to Provide Evidence for Longer‐Term Target Ranges	14
Response to “Misuse of the Term Biorhythms Undermines Chronological Research”	14
Highlighted Articles	14
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
Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity	13
Implementation of DPYD Genotyping in Admixed American Populations: Brazil as a Model Case	13
Moving Toward a Question‐Centric Approach for Regulatory Decision Making in the Context of Drug Assessment	13
Population Pharmacokinetics of Intravenous Methadone Enantiomers in Adults: A Comprehensive Model	13
A Quantitative Systems Pharmacology Model Describing the Cellular Kinetic‐Pharmacodynamic Relationship for a Live Biotherapeutic Product to Support Microbiome Drug Development	13
PBPK Modeling of Entrectinib and Its Active Metabolite to Derive Dose Adjustments in Pediatric Populations Co‐Administered with CYP3A4 Inhibitors	13
ASCPT News	13
Keyword Index	13
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics	13
Prescriber Adoption of SLCO1B1Genotype‐Guided Simvastatin Clinical Decision Support in a Clinical Pharmacogenetics Program	13
Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After Nephrotoxic and Ischemic Injury	13
Biomarkers of Drug‐Induced Kidney Injury: Use in Clinical Trials and Recent Examples of Impact on Drug Development	13
Immune Checkpoint Inhibitors and Venous Thromboembolism: An Analysis of the WHO Pharmacovigilance Database	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
Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology	13
Quantitative Systems Toxicology Predicts Ivacaftor‐Induced Oxidative Stress Contributes to CFTR Modulator Hepatotoxicity	13
How to Run the Pharmacogenomics Clinical Annotation Tool (PharmCAT)	13
Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage Optimization for Patients with Renal Insufficiency or Receiving Continuous Renal Replacement Therapy	13
Population Pharmacokinetics of siRNA JNJ ‐73763989 in Healthy Participants and Patients With Chronic Hepatitis B	13
Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo‐controlled Trial in Constipation	13
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical Development	13
Guided Sample Pooling in Human Mass Balance Studies: A Recommended Strategic Decision Framework	13
Issue Information	13
Progress in Clinical Pharmacology in China: An Ongoing Evolution	13
Ziritaxestat Drug–Drug Interaction with Oral Contraceptives: Role of SULT1E1 Inhibition	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
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
A Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Insulin Dimer	12
Successes and Opportunities during the Pandemic: Reflections and Revelations from a Vaccine Development Perspective	12
Folinic Acid Prophylaxis and Dose Adjustments Enable Safe Treatment with Pemetrexed in Patients with Renal Impairment	12
Clinical Pharmacogenomic MT‐RNR1 Screening for Aminoglycoside‐Induced Ototoxicity and the Post‐Test Counseling Conundrum	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
Breaking Barriers: Characterization of the Intradermal Lipopolysaccharide Challenge as an In Vivo Model for Controlled Induction of Vascular Leakage in H	12
Emerging Tools and Technologies for Microbiome‐Aware Drug Development	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
	12
Role of Cytochrome P450 2C8 in Drug–Drug Interaction between Amiodarone and Nirmatrelvir/Ritonavir Via Physiologically‐Based Pharmacokinetic Modeling	12
Model‐Informed Drug Development‐Based Bridging from Subcutaneous to Intravenous Secukinumab Dosing: Approval in Psoriatic Arthritis and Axial Spondyloarthritis	12
Model‐Informed Precision Dosing Using Machine Learning for Levothyroxine in General Practice: Development, Validation and Clinical Simulation Trial	12
Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With Concomitant Rifampicin: A Dose Escalation Study	12
Promoting Pharmacogenomics in Africa: Perspectives From Variation in G6PD and Other Pharmacogenes	12
Drug Interactions Brewing	12
	12
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib	12
The Pandemic as a Catalyst for Disruptive Innovation in Clinical Pharmacology	12
Dose Titration of Ixazomib Maintenance Therapy in Transplant‐Ineligible Multiple Myeloma: Exposure–Response Analysis of the TOURMALINE‐MM4 Study	12
Psychedelics and Psychotherapy: Is the Whole Greater than the Sum of its Parts?	11
A Multistakeholder Perspective on Advancing Individualized Therapeutics	11
TMS and EEG Pharmacodynamic Effects of a Selective Sphingosine‐1‐Phosphate Subtype 1 Receptor Agonist on Cortical Excitability in Healthy Subjects	11
Population Pharmacokinetics and Exposure–Response Analysis for the CTLA‐4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study	11
	11
Highlights	11
Physiologically Based Pharmacokinetic Modeling to Determine the Impact of CYP2B6 Genotype on Efavirenz Exposure in Children, Mothers and Breastfeeding Infants	11
Challenging the Detection of Comedication Interactions Related to Immune‐Related Adverse Events Using Spontaneous Reporting Systems	11
Use of FDA Expedited Programs and Development Timelines for New Molecular Entity Drug and New Biologic Approvals by Sponsor Experience	11
Translational Modeling as a Tool to Evaluate the Effectiveness of Nalmefene in a Community Setting: A Critical Perspective	11
Investigational Use of Real‐World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma From the Randomized Phase Ib/II MORPHEUS Trial	11
ASCPT NEWS	11
Issue Information	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
Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft‐Versus‐Host Disease	11
Populations Addressed in Vaccines Approved via the European Medicines Agency	11
COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study	11
Mitigating Drug–Target–Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors	11
Impact of the ABCD‐GENE Score on Clopidogrel Clinical Effectiveness after PCI: A Multi‐Site, Real‐World Investigation	11
Issue Information	11
Risk of Acute Kidney Injury Associated With Nephrotoxic Burden in Hospitalized Patients: A Scoping Review	11
A Comparative Clinical Pharmacology Analysis of FDA‐Approved Targeted Covalent Inhibitors vs. Reversible Inhibitors in Oncology	11
Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021	10