38 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "Newcastle University" Fellowship research jobs at Center for Drug Evaluation and Research (CDER)

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

developing comprehensive databases to systematically evaluate the current landscape of in vitro data utilization in drug development. This research will contribute to the development of innovative

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

-analysis to determine appropriate safety strategies to ensure subject safety; and 4) Innovative Biopharmaceutics Assessment Tools - Develop predictive and quantitative methodologies for bioequivalence and

FDA Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

unstructured submission data for model development; 2) Apply AI methods to identify key clinical and biomarker features that drive response to therapy; 3) Contribute to manuscripts, reports, and presentations

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours 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

FDA Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 7 hours 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

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

models (LLMs) to enhance case definition processes by developing a prototype that demonstrates the capability of LLMs to accurately categorize and classify case definitions. The selected fellow will

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

to their novelty and rapid evolution. The research aims to facilitate product development, assist review decision-making, identify regulatory knowledge gaps, and support evidence-based evaluation approaches

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours 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

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

methods for the generic drug research program and conducts regulatory science and research activities based on quantitative approaches. Some of the responsibilities residing in DQMM include providing

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

drug compounding, including, but not limited to specific bulk drug substances that are used in compounding, advancing FDA's development of the Bulk Lists of substances that can be used in human