GDUFA Research Outcomes
Mixture APIs
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are comprised of a mixtures (e.g., polymers) in generic products.
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An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide
Holley, Claire; Cedrone, Edward; Donohue, Duncan; Neun, Barry; Verthelyi, Daniela; Pang, Eric; Dobrovolskaia, Marina