A5014325226- Statistical Methods in Clinical Trials
- Pharmacogenetics and Drug Metabolism
- Cancer Treatment and Pharmacology
- Pharmaceutical studies and practices
- Chronic Lymphocytic Leukemia Research
- Statistical Methods and Bayesian Inference
- Cardiac electrophysiology and arrhythmias
- Acute Lymphoblastic Leukemia research
- Computational Drug Discovery Methods
- Analytical Chemistry and Chromatography
- Receptor Mechanisms and Signaling
- Spectroscopy and Chemometric Analyses
- Advanced Statistical Methods and Models
- Health Systems, Economic Evaluations, Quality of Life
- Biosimilars and Bioanalytical Methods
- Antifungal resistance and susceptibility
- Drug Transport and Resistance Mechanisms
- Neurotransmitter Receptor Influence on Behavior
- Advanced Causal Inference Techniques
- Monoclonal and Polyclonal Antibodies Research
- Phytochemistry and Bioactive Compounds
- Statistical Methods and Inference
- Lung Cancer Treatments and Mutations
- Helminth infection and control
- HER2/EGFR in Cancer Research
Astellas Pharma (United States)
2016-2025
Center for Global Development
2011-2024
Astellas Pharma (China)
2014
University of Manitoba
2013
Case Western Reserve University
2013
GlaxoSmithKline (United States)
2009-2013
Research Triangle Park Foundation
2010-2013
Impact
2013
Quantitative BioSciences
2013
University of Florida
2013
Purpose The receptors for hepatocyte and vascular endothelial cell growth factors (MET VEGFR2, respectively) are critical oncogenic mediators in gastric adenocarcinoma. purpose is to examine the safety efficacy of foretinib, an oral multikinase inhibitor targeting MET, RON, AXL, TIE-2, VEGFR2 receptors, treatment metastatic Patients Methods Foretinib tolerability, objective response rate (ORR) were evaluated patients using intermittent (240 mg/day, 5 days every 2 weeks) or daily (80 mg/day)...
Enfortumab vedotin is an antibody–drug conjugate comprised of a human monoclonal antibody directed to Nectin-4 and monomethyl auristatin E (MMAE), microtubule-disrupting agent. The objectives this review are summarize the clinical pharmacology enfortumab monotherapy demonstrate that appropriate dose has been selected for use. Pharmacokinetics (PK) (antibody–drug total antibody) free MMAE were evaluated in five trials patients with locally advanced or metastatic urothelial carcinoma (n =...
ABSTRACT Isavuconazole, the active moiety of water-soluble prodrug isavuconazonium sulfate, is a triazole antifungal agent used for treatment invasive fungal infections. The objective this analysis was to develop population pharmacokinetic (PPK) model identify covariates that affect isavuconazole pharmacokinetics and determine probability target attainment (PTA) aspergillosis patients. Data from nine phase 1 studies one 3 clinical trial (SECURE) were pooled PPK (NONMEM, version 7.2)....
ABSTRACT Isavuconazole, the active moiety of water-soluble prodrug isavuconazonium sulfate, is a triazole antifungal agent for treatment invasive fungal infections. The purpose this analysis was to characterize isavuconazole exposure-response relationship measures efficacy and safety in patients with aspergillosis infections by other filamentous fungi from SECURE clinical trial. Two hundred thirty-one who received dosing regimen had exposure parameters were included analysis. primary drug...
To characterize alemtuzumab pharmacokinetics and its exposure-response relationship with white blood cell (WBC) count in patients B-cell chronic lymphocytic leukaemia (CLL).Nonlinear mixed effects models were used to plasma concentration-time data WBC count-time from 67 patients. Logistic regression was relate summary measures of drug exposure tumour response.Alemtuzumab best characterized by a two-compartment model nonlinear elimination where V(max) (microg h(-1)) [1020 x (WBC count/10...
The effects of 5-HT are varied and widely distributed throughout the human body. At this time, research is a field ripe for "plucking." Not only there great demand more selective agonists antagonists, but than enough work needed in receptor binding studies to keep pharmacologists employed years come. clinical benefits pharmacology just starting be developed explored. Novel treatments hypertension, migraine headaches, anxiety, depression using beginning. It will exciting see what future holds...
ABSTRACT Isavuconazonium sulfate (Cresemba; Astellas Pharma Inc.), a water-soluble prodrug of the triazole antifungal agent isavuconazole, is available for treatment invasive aspergillosis (IA) and mucormycosis. A population pharmacokinetic (PPK) model was constructed using nonparametric estimation to compare (PK) behaviors isavuconazole in patients treated phase 3 VITAL open-label clinical trial, which evaluated efficacy safety drug renally impaired IA with fungal disease (IFD) caused by...
Abstract Enzalutamide is known to strongly induce cytochrome P450 3A4 (CYP3A4). Furthermore, enzalutamide showed induction and inhibition of P-glycoprotein (P-gp) in vitro studies. A clinical drug-drug interaction (DDI) study between digoxin, a typical P-gp substrate, suggested has weak inhibitory effect on substrates. Direct oral anticoagulants (DOACs), such as apixaban rivaroxaban, are dual substrates CYP3A4 P-gp, hence it recommended avoid co-administration these DOACs with combined...
ABSTRACT The antitumor efficacy of an intratumoral injection a genetically engineered oncolytic vaccinia virus carrying human IL‐7 and murine IL‐12 genes (hIL‐7/mIL‐12‐VV) was demonstrated in CT26.WT ‐bearing mice. In the mouse model, combination hIL‐7/mIL‐12‐VV plus anti‐programmed cell death protein (PD)‐1 antibody determined to be correlated with timing administration: greater observed when administered before anti‐PD‐1 agent instead simultaneous administration. To identify optimal dosing...
Objectives: Weight-based dosing is difficult to accomplish in settings where weighing scales are unavailable, including many regions schistosomiasis treatment needed. However, the accuracy of pediatric weight-estimation strategies can vary widely. We aimed simulate and compare praziquantel exposures that result from use various weight estimation methods.Methods: Sixteen body methods were applied a multinational dataset children (n=1199; 2 < 7 years old) whom anthropometric measures...
Three phase 1 studies of eliglustat tartrate (Genz-112638), an oral inhibitor glucosylceramide synthase under development for treating Gaucher disease type (GD1), evaluated the safety, tolerability, and pharmacokinetics in healthy volunteers after escalating single doses (n = 99), multiple 36), food 24). Eliglustat was well tolerated at ≤ 20 mg/kg 200 mg bid, with 50 bid producing plasma concentrations predicted therapeutic range. No serious adverse events occurred. Mild to moderate nausea,...