Clinical Pharmacology & Therapeutics

Papers
(The TQCC of Clinical Pharmacology & Therapeutics is 7. 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 2021-05-01 to 2025-05-01.)
ArticleCitations
Longitudinal Model‐Based Meta‐Analysis of Lung Function Response to Support Phase III Study Design in Chinese Patients With Asthma475
More Than Pharmacokinetics: Transporters in Clinical Pharmacology277
Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real‐world Data Results from the AlcalUN Study221
ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins – Data in Support of Not Needing Dedicated QTC Studies188
When Can We Rely on Real‐World Evidence to Evaluate New Medical Treatments?174
Estimating Culprit Drugs for Adverse Drug Reactions Based on Bayesian Inference123
The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities108
Neurodegenerative Diseases: The Value of Early Predictive End Points107
Return to SENDer: The Submitted Electronic Data for Nonclinical Cardiovascular Studies is Not Facilitating Transparency, Translation or Innovation102
Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs99
Liquid Biopsies or Therapeutic Drug Monitoring for CYP Activity Profile Determination88
Issue Information86
Advances in Clinical Therapies for Huntington's Disease and the Promise of Multi‐Targeted/Functional Drugs Based on Clinicaltrials.gov82
Pharmacogenomic Prescribing Guidelines: Are They Always Useful?82
Comprehensive Evaluation of OATP‐ and BCRP‐Mediated Drug–Drug Interactions of Methotrexate Using Physiologically‐Based Pharmacokinetic Modeling80
Protecting the Kidney: The Unexpected Logic of Inhibiting a Glucose Transporter69
A Randomized Trial Comparing Standard of Care to Bayesian Warfarin Dose Individualization67
Nicotine Metabolite Ratio Decreases After Switching Off Efavirenz‐Based Therapy in People With HIV Who Smoke62
Reply to “Questioning Bayesian Inference‐Based Models for Estimating Culprit Drugs for Adverse Drug Reactions”61
In This Issue59
ASCPT News58
In This Issue56
How to Successfully Generate an Alternative Approach to a Thorough QT Study: GLPG1972 as an Example55
Effect of CYP3A5 and CYP3A4 Genetic Variants on Fentanyl Pharmacokinetics in a Pediatric Population54
In this Issue53
Progress in Clinical Pharmacology in China: A Randomized Controlled Study to Advance Genotype‐Guided Precision Medicine49
Model‐Based Prediction of Irinotecan‐Induced Grade 4 Neutropenia in Advanced Cancer Patients: Influence of Demographic and Clinical Factors49
Reply to “Interpretation of Pharmacovigilance Disproportionality Analyses”47
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French‐Speaking Network of Pharmacogenetics (RNPGx) Recommendations for Clinical Use of Mavacamten46
Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy Volunteers and Patients with Chronic Kidney Disease46
Infection Risk Associated with High‐Efficacy Disease‐Modifying Agents in Multiple Sclerosis: A Retrospective Cohort Study46
Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B‐Cell Hematological Malignancies45
A Biological Basis for Pharmacokinetics: The Remote Sensing and Signaling Theory44
Machine Learning‐Led Optimization of Combination Therapy: Confronting the Public Health Threat of Extensively Drug Resistant Gram‐Negative Bacteria44
The Broader Context of Liquid Biopsy in Absorption, Distribution, Metabolism, and Elimination44
Using Machine Learning to Individualize Treatment Effect Estimation: Challenges and Opportunities43
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID‐19 Under the Emergency Use Authorization41
Development of a Multifaceted Program for Pharmacogenetics Adoption at an Academic Medical Center: Practical Considerations and Lessons Learned39
Model‐Informed Selection of the Recommended Phase 2 Dosage for Anti‐TIGIT Immunotherapy Leveraging co‐Expressed PD‐1 Inhibitor Target Engagement38
Predicting Survival in Patients with Advanced NSCLC Treated with Atezolizumab Using Pre‐ and on‐Treatment Prognostic Biomarkers38
A Guide for Implementing DPYD Genotyping for Systemic Fluoropyrimidines into Clinical Practice38
Factors Influencing Medication Adherence in Heart Failure Patients—A Survey Among Cardiac Healthcare Providers38
Integrated Evidence Planning for Enhancing Patient Care: Harnessing the Power of Real‐World Evidence37
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An IQ Perspective36
Methodological Insights on Biomarker‐Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency36
Development of Therapeutic Proteins for a New Subcutaneous Route of Administration After the Establishment of Intravenous Dosages: A Systematic Review36
PharmVar GeneFocus: CYP3A536
US Food and Drug Administration's Advancing Real‐World Evidence Program: Initial Experience35
DrugWAS: Drug‐wide Association Studies for COVID‐19 Drug Repurposing34
Impact of Mercaptopurine Metabolites on Disease Outcome in the AIEOP‐BFM ALL 2009 Protocol for Acute Lymphoblastic Leukemia34
Chinese Expert Consensus on the Clinical Diagnosis and Management of Statin Intolerance34
Getting the Dose Right in Drug Development for Rare Diseases: Barriers and Enablers34
Industry Perspective on First‐in‐Human and Clinical Pharmacology Strategies to Support Clinical Development of T‐Cell Engaging Bispecific Antibodies for Cancer Therapy34
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives34
In Memoriam Michelle A. Rudek (1972–2023)34
In this Issue33
ASCPT News33
ASCPT News32
Optimized Alectinib Dose Regimen for Treatment of Patients With ALK‐Positive Non‐Small Cell Lung Cancer Based on Robust Pharmacometric Analyses and Clinical Evidence32
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ASCPT News31
CYP2D6*9 and *41: Does the Activity Value Assigned to these Alleles Need to be Reduced to more Accurately Predict Phenotype?31
Pharmacokinetic‐Pharmacodynamic Modeling of the Ponesimod Effect on Heart Rate in Patients With Multiple Sclerosis31
Highlights31
Clinical Evidence 203030
A Retrospective Analysis of the Potential Impact of Differences in Aggregates on Clinical Immunogenicity of Biosimilars and their Reference Products30
Return of Clinically Actionable Pharmacogenetic Results From Molecular Tumor Board DNA Sequencing Data: Workflow and Estimated Costs30
Development of a Translational Exposure‐Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products30
When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?29
New and Emerging Research on Solute Carrier and ATP Binding Cassette Transporters in Drug Discovery and Development: Outlook From the International Transporter Consortium29
A Case for Synthetic Data in Regulatory Decision‐Making in Europe29
Attaining Equity of Access to Research: Perspective on Research in Pregnancy and Breastfeeding Following Dolores Shockley Lecture at ASCPT202429
Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program29
Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation29
Longitudinal Circulating Tumor DNA Modeling to Predict Disease Progression in First‐Line Mutant Epidermal Growth Factor Receptor Non‐Small Cell Lung Cancer29
ASCPT 125th Anniversary: A Society Leadership Perspective29
Trust in the Food and Drug Administration: A National Survey Study28
ESR1 Variants and Subcontinental Genomic Ancestry: Insights from the 1000 Genomes Project and Native American Populations28
Assessing Correlation between Surrogate Endpoints and Overall Survival for Oncology Clinical Trials27
In This Issue27
Impact of CYP2C19 Phenotype on Escitalopram Response in Geriatrics: Based on Physiologically‐Based Pharmacokinetic Modeling and Clinical Observation27
Subcutaneous Marzeptacog Alfa (Activated) for On‐Demand Treatment of Bleeding Events in Subjects With Hemophilia A or B With Inhibitors27
Highlighted Articles27
The Impact of QT‐Prolonging Medications and Drug–Drug Interactions on QTc Interval Prolongation in Hospitalized Patients: A Case‐Crossover Study26
Issue Information26
The Future of Machine Learning Within Target Identification: Causality, Reversibility, and Druggability26
Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after Kidney Transplantation with Population Pharmacokinetic Modeling26
ASCPT News26
Optimal Treatment Based on Interferon No Longer Makes Clinical Cure of Chronic Hepatitis B Far Away: An Evidence‐Based Review on Emerging Clinical Data26
Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value25
Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development25
Discovering Severe Adverse Reactions From Pharmacokinetic Drug–Drug Interactions Through Literature Analysis and Electronic Health Record Verification25
Model‐Informed Drug Development: Steps Toward Harmonized Guidance24
Corrigendum: Translational Pharmacogenomics: Discovery, Evidence Synthesis, Delivery of Race‐Conscious Medicine24
From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology Modeling in Cancer Immunotherapy24
Is Liquid Biopsy Only Restricted to Diagnostics or Can it Go Beyond the Confines of Genotyping and Phenotyping for Quantitative Pharmacology?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 Cardiovascul24
Clinical and Molecular Perspectives on Inflammation‐Mediated Regulation of Drug Metabolism and Transport24
Viral Kinetics Model of SARS‐CoV‐2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection24
Physiologically Based Pharmacokinetic Modeling to Investigate the Disease‐Drug–Drug Interactions between Voriconazole and Nirmatrelvir/Ritonavir in COVID‐19 Patients with CYP2C1924
Exposure–Response Analyses for Therapeutic Dose Selection of Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma24
Drug Disposition Protein Quantification in Matched Human Jejunum and Liver From Donors With Obesity23
Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective23
A Metabolomic Analysis of Sensitivity and Specificity of 23 Previously Proposed Biomarkers for Renal Transporter‐Mediated Drug‐Drug Interactions23
Participants in the FDA's Biomarker Qualification Program23
Clinical Benefit, Trials, and Regulatory Approval of Oncology Indications Under Multiple Expedited Programs for Drug Marketing in China, 2018–202423
Aging‐Related CYP3A Functional Changes in Chinese Older Patients: New Findings from Model‐Based Assessment of Amlodipine23
Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population‐Based Cohort Study23
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?22
Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All22
Evaluation of the CYP2D6 Haplotype Activity Scores Based on Metabolic Ratios of 4,700 Patients Treated With Three Different CYP2D6 Substrates22
Drug‐Induced Acute Pancreatitis: A Real‐World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database22
Essential (and Largely Untaught) Skills for Clinical Pharmacology in Oncology Drug Development21
Risk of Heart Failure in Rheumatoid Arthritis Patients Treated with Tumor Necrosis Factor‐α Inhibitors21
Donanemab Population Pharmacokinetics, Amyloid Plaque Reduction, and Safety in Participants with Alzheimer's Disease21
Thiopurine Methyltransferase Intermediate Metabolizer Status and Thiopurine‐Associated Toxicity During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia21
Model‐Informed Approach to Recommend Burosumab Dosing Regimens for Pediatric and Adult Patients With the Ultrarare Disease Tumor‐Induced Osteomalacia21
Issue Information21
Multi‐Omics Studies in Historically Excluded Populations: The Road to Equity21
Dapagliflozin Reduces Urinary Kidney Injury Biomarkers in Chronic Kidney Disease Irrespective of Albuminuria Level20
Safety and Dosing Study of a Cholecystokinin Receptor Antagonist in Non‐alcoholic Steatohepatitis20
Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites20
Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study20
Impact of Drug Exposure on Resistance Selection Following Artemether‐Lumefantrine Treatment for Malaria in Children With and Without HIV in Uganda20
Regulatory Issues of Platform Trials: Learnings from EU‐PEARL20
Highlighted Articles20
Warfarin‐Rifampin‐Gene (WARIF‐G) Interaction: A Retrospective, Genetic, Case–Control Study19
Highlights19
Highlights19
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Development in Prescriptions of Contraindicated and Potentially Harmful QT Interval–Prolonging Drugs in a Large Geriatric Inpatient Cohort From 2011 to 202119
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Issue Information19
Personalizing Direct Oral Anticoagulant Therapy for a Diverse Population: Role of Race, Kidney Function, Drug Interactions, and Pharmacogenetics18
ASCPT News18
Population Pharmacokinetic and Exposure–Response Analyses for Efficacy and Safety of Risankizumab in Patients With Active Crohn's Disease18
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper18
Optimal Drug, Optimal Dose, or Both in the Pharmacological Treatment of Neonatal Opioid Withdrawal Syndrome?18
Optimizing Dosage in Pharmacotherapy—Missing the Forest for the Trees18
Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology18
Clinical Actionability of the NUDT15 *4 (p.R139H) Allele and Its Association With Hispanic Ethnicity18
Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions18
A Nomogram to Predict Severe Toxicity in DPYD Wild‐Type Patients Treated With Capecitabine‐Based Anticancer Regimens18
Issue Information18
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective18
Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5‐Year Retrospective Analysis18
The Potential of Disease Progression Modeling to Advance Clinical Development and Decision Making18
Challenges and Possible Strategies to Address Them in Rare Disease Drug Development: A Statistical Perspective18
Ticagrelor versus Adjusted‐Dose Prasugrel in Acute Coronary Syndrome with Percutaneous Coronary Intervention18
Assessment of Efficacy Evidence for Approvals of Novel Drugs in China Between 2018 and 202218
Implementation of NUDT15 Genotyping to Prevent Azathioprine‐Induced Leukopenia for Patients With Autoimmune Disorders in Chinese Population18
Comparative Intra‐Subject Analysis of Gene Expression and Protein Abundance of Major and Minor Drug Metabolizing Enzymes in Healthy Human Jejunum and Liver17
How to Run the Pharmacogenomics Clinical Annotation Tool (PharmCAT)17
ASCPT News17
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Highlighted Articles17
Pharmacogenomic Clinical Decision Support: A Scoping Review17
Development and Validation of the Pharmacological Statin‐Associated Muscle Symptoms Risk Stratification Score Using Electronic Health Record Data17
Prediction of Busulfan Clearance by Predose Plasma Metabolomic Profiling17
Highlights17
Issue Information17
Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID‐19 Trial of Nirmatrelvir17
Fine‐Tuning the Relevance of Molecular Targets to Pediatric Cancer: Addressing Additional Layers of Complexity17
How Much More Efficient Are Adaptive Platform Trials Than Multiple Stand‐Alone Trials? A Comprehensive Simulation Study for Streamlining Drug Development During a Pandemic17
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In this Issue17
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Tacrolimus and Mycophenolic Acid Exposure Are Associated with Biopsy‐Proven Acute Rejection: A Study to Provide Evidence for Longer‐Term Target Ranges16
Immune Checkpoint Inhibitors and Venous Thromboembolism: An Analysis of the WHO Pharmacovigilance Database16
Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage Optimization for Patients with Renal Insufficiency or Receiving Continuous Renal Replacement Therapy16
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics16
Therapeutic Protein Drug Interactions: A White Paper From the International Consortium for Innovation and Quality in Pharmaceutical Development16
Crossing the Chasm: How to Approach Translational Pharmacokinetic–Pharmacodynamic Modeling of Phage Dosing16
Progress in Clinical Pharmacology in China: An Ongoing Evolution16
ASCPT News16
Targeted Use of Placebo Effects Decreases Experimental Itch in Atopic Dermatitis Patients: A Randomized Controlled Trial15
Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo‐controlled Trial in Constipation15
Association of Renal and Cardiovascular Safety With DPP‐4 Inhibitors vs. Sulfonylureas in Patients With Type 2 Diabetes and Advanced Chronic Kidney Disease15
Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–201915
Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic15
Urinary Kidney Injury Biomarker Profiles in Healthy Individuals and After Nephrotoxic and Ischemic Injury15
Implementation of DPYD Genotyping in Admixed American Populations: Brazil as a Model Case15
Prescriber Adoption of SLCO1B1Genotype‐Guided Simvastatin Clinical Decision Support in a Clinical Pharmacogenetics Program15
PBPK Modeling of Entrectinib and Its Active Metabolite to Derive Dose Adjustments in Pediatric Populations Co‐Administered with CYP3A4 Inhibitors15
Quantitative Systems Toxicology Modeling Informed Safe Dose Selection of Emvododstat in Acute Myeloid Leukemia Patients15
The Role of Pharmacogenetics in Smoking15
A Quantitative Systems Pharmacology Model Describing the Cellular Kinetic‐Pharmacodynamic Relationship for a Live Biotherapeutic Product to Support Microbiome Drug Development14
Semimechanistic Population PK/PD Modeling of Axatilimab in Healthy Participants and Patients With Solid Tumors or Chronic Graft‐Versus‐Host Disease14
Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology14
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ASCPT News14
ISPE‐Endorsed Guidance in Using Electronic Health Records for Comparative Effectiveness Research in COVID‐19: Opportunities and Trade‐Offs14
TMS and EEG Pharmacodynamic Effects of a Selective Sphingosine‐1‐Phosphate Subtype 1 Receptor Agonist on Cortical Excitability in Healthy Subjects14
Psychedelics and Psychotherapy: Is the Whole Greater than the Sum of its Parts?14
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Moving Toward a Question‐Centric Approach for Regulatory Decision Making in the Context of Drug Assessment14
Keyword Index14
Promoting Pharmacogenomics in Africa: Perspectives From Variation in G6PD and Other Pharmacogenes14
Clinical Pharmacogenomic MT‐RNR1 Screening for Aminoglycoside‐Induced Ototoxicity and the Post‐Test Counseling Conundrum14
Pharmacokinetic Enhancement of Elexacaftor/Tezacaftor/Ivacaftor for Cystic Fibrosis: A Cost Reduction Strategy to Address Global Disparities in Access13
Precision Reimbursement for Precision Medicine: Using Real‐World Evidence to Evolve From Trial‐and‐Project to Track‐and‐Pay to Learn‐and‐Predict13
Population Pharmacokinetics and Exposure–Response Analysis for the CTLA‐4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study13
Issue Information13
FDA Breakthrough Therapy Designation–Trial Design and More – Commentary13
Investigational Use of Real‐World Data as a Hybrid Control in Pancreatic Ductal Adenocarcinoma From the Randomized Phase Ib/II MORPHEUS Trial13
Japan's Conditional/Time‐Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets13
Successes and Opportunities during the Pandemic: Reflections and Revelations from a Vaccine Development Perspective13
A Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Novel Insulin Dimer13
Role of Cytochrome P450 2C8 in Drug–Drug Interaction between Amiodarone and Nirmatrelvir/Ritonavir Via Physiologically‐Based Pharmacokinetic Modeling13
Dose Titration of Ixazomib Maintenance Therapy in Transplant‐Ineligible Multiple Myeloma: Exposure–Response Analysis of the TOURMALINE‐MM4 Study13
Model‐Informed Precision Dosing Using Machine Learning for Levothyroxine in General Practice: Development, Validation and Clinical Simulation Trial13
Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program13
Pharmacokinetics of Intravenous Paracetamol (Acetaminophen) and Ductus Arteriosus Closure After Premature Birth13
The Pandemic as a Catalyst for Disruptive Innovation in Clinical Pharmacology13
Ziritaxestat Drug–Drug Interaction with Oral Contraceptives: Role of SULT1E1 Inhibition13
COVID‐19 Vaccination and the Incidence of De Novo or Recurrent Rheumatoid Arthritis: A French and International (VigiBase) Signal Detection Study13
Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer13
Physiologically‐Based Pharmacokinetic Modeling to Support Determination of Bioequivalence for Dermatological Drug Products: Scientific and Regulatory Considerations12
Mitigating Drug–Target–Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors12
Leveraging Real‐World Data for EMA Qualification of a Model‐Based Biomarker Tool to Optimize Type‐1 Diabetes Prevention Studies12
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Issue Information12
Impact of the ABCD‐GENE Score on Clopidogrel Clinical Effectiveness after PCI: A Multi‐Site, Real‐World Investigation12
A Comparative Clinical Pharmacology Analysis of FDA‐Approved Targeted Covalent Inhibitors vs. Reversible Inhibitors in Oncology12
Physiologically Based Pharmacokinetic Modeling to Determine the Impact of CYP2B6 Genotype on Efavirenz Exposure in Children, Mothers and Breastfeeding Infants12
Regulator‐Requested Non‐Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review12
Polygenic Risk Scores for Blood Pressure to Assess the Risk of Severe Bevacizumab‐Induced Hypertension in Cancer Patients (Alliance)12
A National Study Among Diverse US Populations of Exposure to Prescription Medications with Evidence‐Based Pharmacogenomic Information12
Mapping the miRNA‐mRNA Interactome in Human Hepatocytes and Identification of Functional mirSNPs in Pharmacogenes12
A Multistakeholder Perspective on Advancing Individualized Therapeutics12
Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan12
Pediatric Rare Diseases Development in the Pharmaceutical Industry: An International Consortium for Innovation and Quality in Pharmaceutical Development, Clinical Pharmacology Leadership Group‐Pediatr12
Effect of Chronic Hepatitis C on the Activity of the Membrane Transporters P‐gp and OATP1B1/BCRP on Patients With Different Stages of Hepatic Fibrosis12
Current Perspectives on Data Sharing and Open Science in Pharmacogenomics12
ASCPT NEWS12
Response to: Real‐World Data on the Risk of Ventricular Arrhythmias with Sulfonamides12
Intracellular Penetration of Atazanavir, Ritonavir and Dolutegravir With Concomitant Rifampicin: A Dose Escalation Study12
Effect of the Proton Pump Inhibitor Esomeprazole on the Systemic Exposure of Capecitabine: Results of A Randomized Crossover Trial11
Acute Effects of Psilocybin After Escitalopram or Placebo Pretreatment in a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Study in Healthy Subjects11
Dose Adjustment in Patients with Liver Cirrhosis – Comparison of Two Different Modeling Approaches11
Artificial Intelligence: From Buzzword to Useful Tool in Clinical Pharmacology11
Clinical Pharmacogenetics Implementation Consortium Guideline for CYP2C19 Genotype and Clopidogrel Therapy: 2022 Update11
Sex and Gender Differences in Clinical Pharmacology: Implications for Transgender Medicine11
Local Ancestry‐Informed Candidate Pathway Analysis of Warfarin Stable Dose in Latino Populations11
Modeling and Simulation to Inform Apixaban Dosing in Pediatrics With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated With Asparaginase11
Pharmacokinetics and Pharmacodynamics of Oral Psilocybin Administration in Healthy Participants11
Features of Inflammatory Heart Reactions Following mRNA COVID‐19 Vaccination at a Global Level11
Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 202111
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