18 parallel-processing-"CEA" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 2 months ago

group. The conventional Dunnett’s type I error rate adjustment proposed in 1955 is for superiority tests with normally distributed data. There are statistical concerns about generalizing the procedure

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

. The participant will inoculate relevant biomanufacturing process fluids with bacteria species to determine potential matrix interference and assay limitations. Results from this study will be reported to the cross

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

-consuming tasks are replaced by streamlined computerized processing that enhances surveillance for timely detection of new emerging issues for drug and inspection related activities. Under the guidance of a

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

research, CDER approved drug products, CDER published guidance including product-specific guidance (PSG), as well as the refinement of processes and infrastructure to analyze and track how research outcomes

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago

database from randomized and controlled clinical trials for drugs intended to treat diabetes, overweight, and lipid disorders, enhancing FDA's safety signal detection capabilities. You will collaborate with

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 17 days ago

. The goal of these quantitative systems pharmacology models is to define a data processing pathway and model validation method that will be used in various areas with particular emphasis on drug polypharmacy

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

review process. Learning Objectives: Under the guidance of the mentor(s),you will develop the following skills during the fellowship; (1) data collection and analysis, (2) clinical pharmacology and

FDA Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

the potential to streamline immunogenicity testing by consolidating the multi-tiered process into a single, more efficient method. While the signal-to-noise ratio approach demonstrates clear advantages

FDA Fellowship - Optimization of Drug-induced Liver Injury Analysis Methods

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

MedDRA preferred terms, and examining racial/ethnic representation in clinical trials. Under the guidance of a mentor, you will also receive training in regulatory review processes, data quality assessment

FDA Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 17 days ago

products is labor intensive and may involve judgment over application procedure and body surface area estimation. To overcome such challenges, this project attempts to approach with AI model(s) in