Clinical therapeutics
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Clinical therapeutics · Aug 2018
Randomized Controlled TrialThe Lack of Effect of Food on the Pharmacokinetics of ZX008 (Fenfluramine Oral Solution): Results of a Single-dose, Two-period Crossover Study.
Fenfluramine is being developed as a low-dose adjunctive treatment for seizures in patients with Dravet syndrome and other epileptic encephalopathies, including Lennox-Gastaut syndrome. Most patients with Dravet syndrome receive multiple antiepileptic drugs, making it challenging for caregivers to track correct administration times. The present Phase I study was conducted to determine the effect of food on the pharmacokinetic properties of fenfluramine. ⋯ The bioequivalence and tolerability of single 0.8-mg/kg oral doses of ZX008 in the fed and fasted states support ZX008 administration without regard to meals.
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Clinical therapeutics · Aug 2018
Randomized Controlled TrialRelative Oral Bioavailability of an Abuse-deterrent, Extended-release Formulation of Morphine Versus Extended-release Morphine: A 2-period, Single-dose, Randomized Crossover Study in Healthy Subjects.
Morphine ARER is a novel oral, abuse-deterrent, extended-release (ER) formulation of morphine sulfate with physical and chemical properties that deter misuse and abuse by nonoral routes of administration. Here we evaluate the relative bioavailability of morphine ARER and extended-release morphine. ⋯ These data show that, in these subjects, morphine ARER was bioequivalent to ER morphine, a treatment for pain with well-established efficacy and safety profiles.
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Clinical therapeutics · Aug 2018
Observational StudyEmergency Medicine Resident Self-assessment of Clinical Teaching Compared to Student Evaluation Using a Previously Validated Rubric.
The quality of clinical teaching in the emergency department from the students' perspective has not been previously described in the literature. Our goals were to assess senior residents' teaching ability from the resident/teacher and student/learner viewpoints for any correlation, and to explore any gender association. The secondary goal was to evaluate the possible impact of gender on the resident/student dyad, an interaction that has previously been studied only in the faculty/student pairing. ⋯ MS and PA students evaluated teaching by EM senior residents statistically significantly higher than did EM residents on self-evaluation when using the ER Scale. Students did not evaluate residents' teaching with any difference by gender, although male residents routinely self-assessed their teaching abilities more positively than did female residents. These findings suggest that, if residency programs utilize resident self-evaluation for programmatic evaluation, the gender of the resident may impact self-scoring. This cohort may inform future study of resident teaching in the emergency department, such as the design of future resident-as-teacher curricula.