56 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "University of Waterloo" positions at Center for Drug Evaluation and Research (CDER)

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 7 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 Clinical Pharmacology / Model Informed Drug Development

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

are made for nucleotide-based therapeutics—such as antisense oligonucleotides, siRNA, and mRNA—intended for neurological diseases. The you will help investigate how safety margins, nonclinical data

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

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

considering all the data, not just subgroup specific data. A BHM assumes exchangeability in treatment effects across subgroups after adjusting for effect modifiers and other relevant covariates. In this project

FDA Dosage Optimization of Antibody-Drug Conjugates

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

therapeutics and generic drugs. This effort covers more than just medicines. Research Project: The project will collect data on the characteristics and exposure-response relationships for currently approved

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 7 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

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

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

related to pharmaceutical quality, lifecycle management of drug products, and data analytics and modeling to support regulatory decision making. The participant will acquire the above mentioned through

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

 contribute to projects that are mandated under the 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use or risks from sources other than clinical trials

FDA Fellowship - Elsa API integration and Development of Advanced User Interface for InfoViP

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 7 hours ago

, pharmacoepidemiology methods development). You will have learning opportunities that include: Understanding of pharmacovigilance data analysis workflows; Full-stack web-based application development; Integration

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 7 hours ago

for industry guidance, and the quality assessment of drug products for benzene contamination. You will conduct data interpretation and evaluation, gain regulatory process knowledge, conduct experiments, and

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

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

adherence and associated treatment failure. Given the paucity of data in pregnancy and lactation, model-based approaches (such as physiologically-based pharmacokinetic (PBPK) modeling) are being employed