38 linked-data-"https:"-"https:"-"https:"-"Embry-Riddle-Aeronautical-University" Fellowship 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 16 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 16 hours ago
electrophysiology to assess mechanisms of drug effects on cardiac and neuronal ion channels critical for safety evaluation. Additionally, the research will include advanced statistical modeling for data analysis and
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago
products, with no clinically meaningful differences in safety, purity, or potency. Despite advances in analytical and functional characterization, establishing a robust quantitative link between analytical
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 16 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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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago
, including biological therapeutics and generic drugs. This effort covers more than just medicines. Research Project: CDER has recently begun storing both electronic toxicology study data and nonclinical
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago
intelligence-enabled opioid pharmacovigilance and inspection software application that advances drug safety surveillance by integrating real-world data and regulatory data. The new comprehensive multi-resource
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago
analyzing data within the Center for Drug Evaluation and Research (CDER) drug submission database. The project will help modernize CDER’s data analytics capabilities and support FDA’s mission to protect
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago
a multidisciplinary team to develop frameworks for standardizing and combining subject-level data from hundreds of clinical trials, including over 20 completed cardiovascular outcome trials. You will
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago
mathematical ADA model to provide quantitative immunogenicity assessment for therapeutic proteins. This model was constructed using antibody titer data from subjects across 10 clinical trials, with ADA time
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago
, there are only animal data to inform the safety in pregnant and lactating women. Pregnancy safety and lactation data are collected predominantly in the post approval setting. The 2007 FDA Amendments Act gave FDA