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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago
drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: This research project aims to develop quantitative structure-activity relationship
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Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 12 hours ago
other modern analytical techniques to perform structural characterization of oligonucleotides. You will learn to employ a higher-dimensional analytical platform for analyzing complex molecules. Laboratory
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago
regulatory assessments, and strengthen critical-thinking and scientific communication skills to support evidence-based decision-making in drug development. Under the guidance of a mentor, structured learning
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago
for predictive model validation, and developing AI, statistical, or mechanistic models to translate nonclinical data (such as chemical structures, sequences, and in vitro functional assays for specific drugs
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago
drug exposure and contribute to the FDA’s ongoing efforts to ensure the safety of medications used during lactation. Learning Objectives: Under the guidance of the mentor, you will receive structured
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago
components and research activities will include: Structured learning sessions on FDA's immunogenicity guidance documents and regulatory framework Collaborating with experienced FDA reviewers to understand
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago
) learn about biologic products and the regulatory evaluation of biosimilars; 2) use AI/ML to model relationships between molecular structures, biological responses, and clinical outcomes; 3) assess
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago
on how co-use should be evaluated for impairment. Learning Objectives: The fellowship will provide structured learning opportunities in clinical pharmacology, pharmacokinetics, regulatory science
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 12 hours ago
high-volume data to prepare for modeling; Learn how to adjust model structures/parameters based on calibration data, and evaluate model credibility using validation data; Learn how to execute modeling