36 web-developer-"https:"-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

drug. Historically, increases in liver enzymes (ALT and AST) has been used to identify subjects with potential DILI during drug development. However, local laboratory normal reference ranges can vary

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

microfluidic devices; 2) Barrier function and transport studies (including permeability assays and imaging-based analyses); 3) Analytical method development using fluorescence microscopy, ELISA, and LC–MS

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

analytical tools Learning research database design principles and data management best practices Contributing to development of evidence-based recommendations for regulatory policy enhancement Participating in

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 | 23 days ago

developed for superiority testing and analyze their performance when applied to bioequivalence assessments involving multiple test formulations compared against a common reference product. Participants will

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

molecular attributes and biological responses. This project proposes to develop an AI/ML-integrated translational framework that associates analytical quality parameters to PK, immunogenicity, and safety

FDA Fellowship - Strategies to Identify Cases of Prenatal Drug Exposure in FAERS

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

strategies and a novel search strategy. You will collaborate with the research team to interpret findings and develop materials to disseminate best practices to FDA staff. Through the appointment, you will