Publications by authors named "Trupti Dixit"
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.
The acceptability of pediatric pharmaceutical products to patients and their caregivers can have a profound impact on the resulting therapeutic outcome. However, existing methodology and approaches used for acceptability assessments for pediatric products is fragmented, making robust and consistent product evaluations difficult. A pediatric formulation development workshop took place in Washington, DC in June 2016 through the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI).
View Article and Find Full Text PDFElucidation of the metabolism and pharmacology of 1,2,3-triazolines (TRs) led to the identification of the triazoline pharmacophore and the evolution of the aminoalkylpyridines (AAPs). The AAPs have no activity in the scMet test but are highly effective in the MES seizure test by the oral route. The AAPs bind to the sigma(1) receptor with low affinity, but high selectivity.
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