Publications by authors named "A Selen"

Objective: Language disorder, a prevalent developmental disorder, impedes children's communication skills, with genetic and environmental factors playing pivotal roles in its pathomechanism. This study aims to investigate the involvement of sequence variations in and genes, along with environmental variables, in language disorder's etiology.

Methods: Between September 2022 and March 2023, thirty children aged 2-7 diagnosed with language disorders according to DSM-5 criteria, and evaluated using the Ankara Developmental Screening Inventory, were studied to identify genetic and environmental factors contributing to etiology.

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Objective: Patient acceptance of pediatric formulations is critical to compliance and consequently therapeutic outcomes; thus, having an method to evaluate sensory perception of pharmaceutical products would be beneficial. The objective of this research is to develop a sensitive and reproducible tribological method to characterize pharmaceutical suspensions at low force and sliding speeds.

Methods: The discriminating potential of the method was examined using tribology profiles (coefficient of friction (COF) vs.

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A pediatric formulation workshop entitled "Pediatric Formulations: Challenges of Today and Strategies for Tomorrow" was held to advance pediatric drug product development efforts in both pre-competitive and competitive environments. The workshop had four main sessions discussing key considerations of Formulation, Analytical, Clinical and Regulatory. This paper focuses on the clinical session of the workshop.

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Article Synopsis
  • A two-day workshop on pediatric formulation development was held in June 2019, organized by M-CERSI, the FDA, and the IQ Drug Product Pediatric PWG, bringing together diverse participants from industry, regulatory bodies, and academia.
  • The workshop included sessions that covered formulation challenges, analytical strategies, clinical considerations, and regulatory insights, with a focus on improving drug product acceptability for pediatric use.
  • Key topics discussed involved dosing vehicle selection, the impact of pediatric pharmacokinetics on drug design, regional regulatory differences, and collaboration opportunities for advancing pediatric formulations.
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To increase the understanding of how drugs behave following oral administration to the pediatric population, the aim of the present study was to investigate the solubilization of fluconazole and ibuprofen during simulated gastro-intestinal (GI) digestion, using an immediate transfer model mimicking pediatric GI digestion. The effects of infant formula and digestion, on the drug solubilization, were studied using simulated fasted and fed state digestion media in the presence and absence of digestive enzymes. Additionally, the effect of digestion media viscosity on the solubilization process was investigated.

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