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This study was performed to estimate the population pharmacokinetic (PK) parameters of etanercept in pediatric juvenile rheumatoid arthritis (JRA) patients and to compare the steady-state time-concentration profiles between etanercept 0.8-mg/kg once-weekly and 0.4-mg/kg twice-weekly subcutaneous (SC) regimens by clinical trial simulation. To this end,(More)
BACKGROUND Patients with large vestibular schwannomas are at high risk of poor facial nerve (cranial nerve VII [CNVII]) function after surgery. Subtotal resection potentially offers better outcome, but may lead to higher tumor regrowth. OBJECTIVE To assess long-term CNVII function and tumor regrowth in patients with large vestibular schwannomas. METHODS(More)
OBJECTIVE Our objective was to develop a population pharmacokinetic and pharmacodynamic model of etanercept in patients with rheumatoid arthritis, with the American College of Rheumatology response criterion of 20% improvement (ACR20) used as a binary clinical outcome variable. METHODS Concentration-time profiles from 25 subjects, administered 25 mg(More)
The population pharmacokinetics of subcutaneously administered golimumab (50 mg or 100 mg every 4 weeks) were characterized in patients with active psoriatic arthritis (PsA) in GO-REVEAL, a randomized, double-blind, placebo-controlled, phase 3 study. A total of 2029 serum golimumab concentrations from 337 patients were analyzed using NONMEM. A 1-compartment(More)
AIMS Obesity and physical inactivity are known to be risk factors for many chronic diseases including hypertension, coronary artery disease, diabetes, and cancer. We sought to explore the association between an indicator of transportation data (Vehicle Miles of Travel, VMT) at the county level as it relates to obesity and physical inactivity in California.(More)
BACKGROUND We would like to assess the safety and effectiveness of prophylactic percutaneous endoscopic gastrostomy (PEG) tube feedings during concurrent chemoradiation for head and neck cancer. METHODS Patients who underwent chemotherapy and radiation for head and neck malignancies were evaluated for their ability to resume oral feeding following(More)
CT-P13, the world’s first biosimilar monoclonal antibody to infliximab, was approved for marketing in South Korea for all the six indications of infliximab, which Europe may follow, although the product was tested only in rheumatoid arthritis (RA) with a limited pharmacokinetic comparison in ankylosing spondylitis. However, the extrapolation of the efficacy(More)
The population pharmacokinetic (PK) profile of oral clonidine was characterized in newborns with neonatal abstinence syndrome, and significant covariates affecting its PK parameters were identified. Plasma clonidine concentration data were obtained from a clinical trial in which 36 newborns, aged 1 to 25 days (postnatal age, PNA) and weighing 2.1 to 3.9 kg,(More)
BACKGROUND AND OBJECTIVES Fimasartan (BR-A-657) is a novel, non-peptide angiotensin II receptor antagonist with a selective type I receptor blockade effect. Two first-in-human studies investigated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of fimasartan. METHODS Fasted single oral tablet doses of fimasartan 20-480 mg or(More)