Services and Capabilities

GLP studies are conducted according to the FDA’s standards set in 21 CFR part 58. One of the major bottlenecks limiting successful new drug development is preclinical safety.   Inhaled drug formulations can be particularly challenging during preclinical testing due to complexities involved in drug aerosolization.   Additionally, for IND-enabling studies, the FDA requires that Good Laboratory Practices (GLP) be implemented and followed closely throughout a project.   To address these challenges, UT Advance has combined its aerosol expertise and regulatory oversight to assist in progressing inhaled drug products to the clinic.  Using highly controlled aerosol exposure systems and advanced characterization tools, our studies offer dose control for both traditional and engineered formulations.  In partnership with TherapeUTex, UT Advance can also assist with pharmacokinetic, non-GLP toxicity, and efficacy studies where a precisely controlled aerosol dose is needed.

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