Assessment of an In Silico Mechanistic Model for Proarrhythmia Risk Prediction Under the CiPA Initiative
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1184
Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1426
M281, an Anti‐FcRn Antibody: Pharmacodynamics, Pharmacokinetics, and Safety Across the Full Range of IgG Reduction in a First‐in‐Human Study
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1276
Development of the PGx‐Passport: A Panel of Actionable Germline Genetic Variants for Pre‐Emptive Pharmacogenetic Testing
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1489
General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1647
Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1638
Pharmacogenomics of Vincristine‐Induced Peripheral Neuropathy Implicates Pharmacokinetic and Inherited Neuropathy Genes
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1179
Abemaciclib Inhibits Renal Tubular Secretion Without Changing Glomerular Filtration Rate
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1296
Physiologically‐Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug–Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1693
Genomewide Association Study of Statin‐Induced Myopathy in Patients Recruited Using the UK Clinical Practice Research Datalink
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1557
A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1565
A PK/PD Analysis of Circulating Biomarkers and Their Relationship to Tumor Response in Atezolizumab‐Treated non‐small Cell Lung Cancer Patients
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1198
Examining the Use of Real‐World Evidence in the Regulatory Process
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1658
Pharmacogenomics Clinical Annotation Tool (PharmCAT)
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1568
Calling Star Alleles With Stargazer in 28 Pharmacogenes With Whole Genome Sequences
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1552
Exposure–Response Analyses of Upadacitinib Efficacy in Phase II Trials in Rheumatoid Arthritis and Basis for Phase III Dose Selection
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1543
Vedolizumab for Inflammatory Bowel Disease: Two‐Year Results of the Initiative on Crohn and Colitis (ICC) Registry, A Nationwide Prospective Observational Cohort Study
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1712
Pharmacokinetics, Safety, and Tolerability of Tezepelumab (AMG 157) in Healthy and Atopic Dermatitis Adult Subjects
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1401
Relationship Between Benralizumab Exposure and Efficacy for Patients With Severe Eosinophilic Asthma
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1371
Pediatric Anthracycline‐Induced Cardiotoxicity: Mechanisms, Pharmacogenomics, and Pluripotent Stem‐Cell Modeling
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1311
Evaluation of the Effects of a Monthly Buprenorphine Depot Subcutaneous Injection on QT Interval During Treatment for Opioid Use Disorder
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1406
Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1696
Exposure–Response Relationships for Efficacy and Safety of Risankizumab in Phase II and III Trials in Psoriasis Patients
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1594
A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1480
Small But Mighty: The Use of Real‐World Evidence to Inform Precision Medicine
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1466
Improving the Safety of Medicines in the European Union: From Signals to Action
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1678
Repurposing of Diagnostic Whole Exome Sequencing Data of 1,583 Individuals for Clinical Pharmacogenetics
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1665
Digital Learning to Improve Safe and Effective Prescribing: A Systematic Review
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1549
Enantiospecific Pharmacogenomics of Fluvastatin
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1463
Genomic Variation and Pharmacokinetics in Old Age: A Quantitative Review of Age‐ vs. Genotype‐Related Differences
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1057
Dual Roles for the TSPYL Family in Mediating Serotonin Transport and the Metabolism of Selective Serotonin Reuptake Inhibitors in Patients with Major Depressive Disorder
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1692
Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1047
Risk of Myocardial Infarction Among New Users of Calcium Supplements Alone or Combined With Vitamin D: A Population‐Based Case‐Control Study
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1636
The Missing Reality of Real Life in Real‐World Evidence
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1465
Pharmacogenomics in Practice
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1600
Real‐World Data: An Unrealized Opportunity in Global Health?
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1476
Neural architecture influences rTMS-induced functional change: a DTI and FMRI study of cue-reactivity modulation in alcohol users.
来源期刊:Clinical pharmacology and therapeuticsDOI:10.1002/cpt.1545
Association of Statin and Its Lipophilicity With Cardiovascular Events in Patients Receiving Chronic Dialysis
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1722
Comparison of Different Strategies to Measure Medication Adherence via Claims Data in Patients With Chronic Heart Failure
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1378
The Current and Future Potential of TMS-EEG in Psychiatry.
来源期刊:Clinical pharmacology and therapeuticsDOI:10.1002/cpt.1541
Anastrozole Aromatase Inhibitor Plasma Drug Concentration Genome‐Wide Association Study: Functional Epistatic Interaction Between SLC38A7 and ALPPL2
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1359
Interchangeability of Generics—Experiences and Outlook Toward Pharmacokinetics Variability and Generic‐Generic Substitution
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1250
Broad‐Spectrum Profiling of Drug Safety via Learning Complex Network
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1750
“Thorough QT/QTc in a Dish”: Can Human Induced Pluripotent Stem Cell–Derived Cardiomyocytes Predict Thorough QT Outcomes?
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1384
Trials in “True” Dyslipidemic Patients Are Urged to Reconsider Comprehensive Lipid Management as a Means to Reduce Residual Cardiovascular Risk
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1436
Are EMA, FDA and other international regulators talking to each other?
来源期刊:Clinical pharmacology and therapeuticsDOI:10.1002/cpt.1617
A Patient‐Centric Model for Discontinuation of a Single‐Sourced Approved Drug
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1411
A new liver eQTL map from 1,183 individuals provides evidence for novel eQTLs of drug response, metabolic and sex-biased phenotypes.
来源期刊:Clinical pharmacology and therapeuticsDOI:10.1002/cpt.1751
A Framework Proposal to Follow‐Up on Preclinical Convulsive Signals of a New Molecular Entity in First‐in‐Human Studies Using Electroencephalographic Monitoring
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1455
Path Toward Proactive Therapy for Patent Ductus Arteriosus
来源期刊:Clinical Pharmacology and TherapeuticsDOI:10.1002/cpt.1583