32 finite-element-analysis research jobs at Center for Drug Evaluation and Research (CDER)

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

the principles of scientific analysis. You will research specific bulk drug substances that are being evaluated by FDA, advancing FDA's development of the Bulk Lists of substances that can be used in human

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

and optimize drug-induced liver injury (DILI) analysis methods to address poor data quality issues. Training activities will include collating DILI subjects from 2024 approved NDAs/BLAs, analyzing

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 month ago

the principles of scientific analysis. You will research specific bulk drug substances that are being evaluated by FDA, advancing FDA's development of the Bulk Lists of substances that can be used in human

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 12 days ago

framework for selecting (primary) endpoint strategies and determining the corresponding statistical analysis plan for non-malignant hematologic diseases in confirmatory trials, starting with the use

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 | 12 days ago

that traditional clinical assessments may miss. Our published proof-of-concept study demonstrated that PRO-CTCAE-derived ER analysis may offer enhanced sensitivity, and to complement standard ER analysis, by

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

evaluation, active ingredient sameness demonstration, and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining, and establishes the scientific

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

-course profiles characterized through a two-component semi-mechanistic model that captured the characteristic double-peak pattern of antibody responses. We also explored relationships between antibody

FDA Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 12 days ago

will: Gain foundation knowledge in antiretroviral drug classes, meta-analysis methodologies, clinical trial data analysis, and R programming. Training in this area will occur through a structured program

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 12 days ago

macular edema (DME), with potential expansion to other retinal indications, through network meta-analysis and patient matching methodologies applied to historical and recent clinical data. The participant

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 12 days ago

prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: Maximum daily dose (MDD) refers to the highest amount of active ingredient