U.S. Food and Drug Administration (FDA) Clinical Pharmacology / Model Informed Drug Development
A full-time ORISE fellowship at FDA CDER (White Oak, MD) to conduct regulatory-science research on dose selection and optimization for nucleotide-based neurologic therapies (antisense oligos, siRNA, mRNA) using model-informed drug development (MIDD). Fellows will review FDA regulatory documents, extract and synthesize evidence on safety margins, nonclinical data, biomarkers and PK/PD to produc…
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