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Agency:    Department of Defense--Military
Bureau:    Research, Development, Test, and Evaluation
Account:    Research, development, test, and evaluation, Army (21-2040)
Certifying Official:    Deputy Comptroller Program/Budget
Contact Information:    http://WWW.DOD.GOV   703-697-5131
Clinical Trials Using a Piezoelectric Dry Powder Inhalation Device

1 recipient will receive $4,000,000. This is a continuing earmark.
Year Enacted: 2005
Description: This project will demonstrate that a new Dry Powder Inhaler (DPI) is a viable replacement for the military's Medical Aerosolized Nerve Agent Antidote (MANAA). The development plan includes Investigational New Drug submission followed by a Phase I bioavailability/ bioequivalence study in approximately 20 subjects. A gamma scintigraphy study will be conducted as a follow-on study and performed with similar devices manufactured and tested under good manufacturing practices. Device formulation will be finalized and an additional volunteer trial may be conducted to confirm the final formulation and device perform consistently. A protocol/ study will be performed to compare the new product with MANAA. The results will be reviewed with the Food and Drug Administration and will form the basis of a New Drug Application.
Beneficiary/Recipient Amount ($K) Program Type Address
University of Pittsburg $4,000 Public Educational Institution
Pittsburgh, PA
Source: Appropriations Report Language - Conference
Reference: 108-622
Location: Line 29, Page 255
Citation Excerpt: Clinical Trials Using a Piezoelectric Dry Powder Inhalation Device

Last Modified: 16-Apr-2007

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