FDA Research Opportunity Focuses on Dose Selection for Inflammatory Bowel Disease Products
The U.S. Food and Drug Administration (FDA), specifically its Center for Drug Evaluation and Research (CDER), is offering a research opportunity focused on improving dose selection for products used in inflammatory bowel disease (IBD). This project, based in White Oak, Maryland, aims to support safer and more effective pediatric therapeutics by generating better evidence on dosing. The research will involve examining dose-selection strategies in clinical development programs for IBD products, comparing approved doses across age groups and indications, and studying how patient-specific factors like age, body size, disease activity, and immunogenicity influence pharmacokinetics, pharmacodynamics, and therapeutic response.
