80 developer-"https:"-"https:"-"https:"-"Univ"-"Gustave-Roussy-" positions at Center for Drug Evaluation and Research (CDER) in United States
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago
, biomarkers, and model-informed drug development (MIDD) approaches inform final dose selection. Key activities will include reviewing FDA regulatory documents such as Pre-IND communications, End-of-Phase 2 and
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago
the guidance of the mentor, you will learn state-of-the-art technologies and develop novel technologies for feasible analysis of glycosylation of therapeutic glycoprotein drugs, including monoclonal antibody
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Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 17 days ago
). The project is to develop liquid chromatography-mass spectrometry (LC-MS) methods for the analysis of nitrosamine impurities in drug products and apply the developed and validated methods to screen
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago
disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data
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., drug safety, substance use disorders, pharmacovigilance, pharmacoepidemiology methods development). Through this fellowship, you will have opportunities to learn: Understanding of pharmacovigilance
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capabilities (through API calls) into the InfoViP platform while developing an enhanced user interface that incorporates various functionalities to support adverse event analysis. Learning Objectives: You will
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago
BLA submissions and published literature to cooperate in model building, covariate selection, and quantitative tool development. The findings are expected to be applied to innovate clinical trial design
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days 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) | Southern Md Facility, Maryland | United States | 17 days ago
therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: The project involves using FDA’s AI tool ‘Elsa,’ which uses either Claude Sonnet or Gemini models, to develop
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago
challenge to pediatric drug development especially for the younger children. Some of the challenges in using pediatric drug-device combination products include the delivery of inadequate doses for achieving