Results 211 to 220 of about 79,005 (311)

The Visual Predictive Check and Real‐World Data

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The visual predictive check (VPC) is a standard tool for assessing pharmacometric model suitability, producing visualizations that compare observed data with simulated data such that both model structure and model variability terms can be assessed. However, real‐world data commonly reflect clinical decision‐making that adapts therapy in response to ...
Jasmine H. Hughes   +2 more
wiley   +1 more source

Anifrolumab Dose Regimen Selection for a Phase 3 Trial in Lupus Nephritis

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
In patients with systemic lupus erythematosus (SLE), increased type I interferon signaling is associated with increased disease activity across organs, including in the kidney, which can cause lupus nephritis (LN). Anifrolumab, which abrogates type I interferon signaling, is an approved treatment for moderate to severe SLE.
Joachim Almquist   +6 more
wiley   +1 more source

Mind the Gap: Addressing Missing Person Time When Estimating Outcome Incidence in Longitudinal Data. [PDF]

open access: yesEpidemiology
Rudolph JE   +7 more
europepmc   +1 more source

Prediction of Acute Liver Injury Trajectory in Patients Following Acetaminophen Overdose: A Multibiomarker Machine Learning Proof‐of‐Concept Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Clinical translation of novel therapies can be hindered by heterogeneity‐driven sample size inflation in late‐stage trials. In acetaminophen‐induced liver injury (APAP DILI), many patients recover spontaneously, diluting investigational drug efficacy signals.
Chris Humphries   +8 more
wiley   +1 more source

Impact of CYP2C19 and CYP3A4 Inhibitor Use on Clopidogrel Clinical Effectiveness in CYP2C19 Genotyped Patients Undergoing Percutaneous Coronary Intervention

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
CYP2C19 and CYP3A4 contribute to clopidogrel bioactivation. CYP2C19 no‐function alleles diminish clopidogrel's antiplatelet effects and clinical effectiveness. Coadministration of either a CYP2C19 or a CYP3A4 inhibitor may also reduce clopidogrel's antiplatelet effects and lead to phenoconversion in patients without a CYP2C19 no‐function allele (normal/
Danwei Shao   +8 more
wiley   +1 more source

Statistical Methods for Chimeric Antigen Receptor Cell Therapy Outcomes: A Review and Practical Considerations. [PDF]

open access: yesTransplant Cell Ther
Kim S   +6 more
europepmc   +1 more source

Ruxolitinib Pharmacokinetics and Exposure–Toxicity Relationship in Hematologic Malignancies and Immune‐Mediated Diseases: A Prospective Observational Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Ruxolitinib pharmacokinetics (PK) has been characterized in clinical trials but remains poorly documented in real‐world practice. This project aimed to investigate ruxolitinib PK in routine clinical practice, identify factors driving its variability, and explore exposure–response relationships to assess the potential role of therapeutic drug monitoring.
Jérémie Tachet   +11 more
wiley   +1 more source

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