21 data-"https:" "https:" "https:" "https:" "https:" "https:" "SciLifeLab" positions at Center for Drug Evaluation and Research (CDER)
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
efficacy in children often based on data in adults based on assumptions or evidence of disease and response similarity between adults and children. The critical need to systematically assess extrapolation
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
collaborate with FDA scientists to compile immunogenicity assessment data from multiple regulatory sources, including Biologics License Applications (BLAs), validation reports, and clinical pharmacology review
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
adherence and associated treatment failure. Given the paucity of data in pregnancy and lactation, model-based approaches (such as physiologically-based pharmacokinetic (PBPK) modeling) are being employed
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
or limited multivariate analysis. However, the increasing dimensionality and complexity of analytical data demand AI/ML-based frameworks capable of learning nonlinear, high-dimensional relationships between
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
Office of New Drugs (OND) are creating new and updating existing toxicity databases based on available nonclinical animal data (and available clinical data where applicable) that could be used in
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
evaluation, active ingredient sameness demonstration, and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining, and establishes the scientific
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
: Conduct literature searches on specific monograph drug active ingredients using regulatory science databases and evaluate scientific evidence supporting safety and effectiveness determinations. Data
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
(QSAR) models. The selected participant will learn to harvest and interpret toxicology data, develop and apply QSAR models, and communicate research results to both internal and external stakeholders
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macular edema (DME), with potential expansion to other retinal indications, through network meta-analysis and patient matching methodologies applied to historical and recent clinical data. The participant
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago
barrier integrity and permeability, and compare in vitro findings with available clinical and pharmacokinetic data to assess model performance. These activities will advance understanding of maternal–infant