36 web-developer-"https:"-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)
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both the development and regulation of oligonucleotide drugs. Learning Objectives: Under the guidance of the mentor, you will receive instructions on utilizing chromatography, mass spectrometry, and
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
quantitative method support for guidance development, abbreviated new drug application (ANDA) reviews, citizen petitions, controlled correspondence, pre-ANDA meetings, methodology development for bioequivalence
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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) | Southern Md Facility, Maryland | United States | 1 day ago
(PROs) represent the only quantitative tool available to assess tolerability of oncologic agents under development, providing unique insights into the patient experience of symptomatic adverse events
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
development have been restricted to juvenile animal studies for the past 20 years. The FDA program to reduce, refine and replace animal studies has stimulated an important discussion about both increasing
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
, additional research is needed to establish its utility for quantitatively characterizing ADA time-course profiles compared to traditional tiered approaches. In our previous research, we developed a
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
. Serotonin promotes the growth of fetal heart cells while abnormal or blocked serotonin levels can change heart development. Understanding the mechanisms responsible for this association is crucial
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
reviewers' conclusions in queryable databases; however, reviewer conclusions are only successfully recorded for a subset of the toxicology study data submitted. These databases will be utilized to train