4 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "University of Waterloo" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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 Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

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

FDA Clinical Pharmacology of Novel Modality Biological Products

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

, data analysis, and regulatory submission evaluations to identify knowledge gaps and establish best practices for assessment. You will analyze clinical trial datasets to characterize dose-response

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day ago

dose selection based on adult data and patient-specific factors. Specifically, the fellow will: Survey clinical development programs for IBD products, focusing on dose-selection strategies for adults and