55 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Edinburgh Napier University" positions 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 9 hours ago

electrophysiology to assess mechanisms of drug effects on cardiac and neuronal ion channels critical for safety evaluation. Additionally, the research will include advanced statistical modeling for data analysis and

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

efficacy in children often based on data in adults based on assumptions or evidence of disease and response similarity between adults and children. The critical need to systematically assess extrapolation

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

collaborate with FDA scientists to compile immunogenicity assessment data from multiple regulatory sources, including Biologics License Applications (BLAs), validation reports, and clinical pharmacology review

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

intelligence-enabled opioid pharmacovigilance and inspection software application that advances drug safety surveillance by integrating real-world data and regulatory data. The new comprehensive multi-resource

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

, including biological therapeutics and generic drugs. This effort covers more than just medicines. Research Project: CDER has recently begun storing both electronic toxicology study data and nonclinical

FDA Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

analyzing data within the Center for Drug Evaluation and Research (CDER) drug submission database. The project will help modernize CDER’s data analytics capabilities and support FDA’s mission to protect

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours 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

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

patients is challenging. The objective of this project is to develop a pediatric oncology database by collecting data from pediatric study protocols, regulatory marketing applications and FDA review

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

mathematical ADA model to provide quantitative immunogenicity assessment for therapeutic proteins. This model was constructed using antibody titer data from subjects across 10 clinical trials, with ADA time

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours ago

, there are only animal data to inform the safety in pregnant and lactating women. Pregnancy safety and lactation data are collected predominantly in the post approval setting. The 2007 FDA Amendments Act gave FDA