Development of realistic in vitro studies to assess robustness of dose counters/indicators in metered dose inhalers (U01)

The summary for the Development of realistic in vitro studies to assess robustness of dose counters/indicators in metered dose inhalers (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food Drug Administration, which is the U.S. government agency offering this grant.
Development of realistic in vitro studies to assess robustness of dose counters/indicators in metered dose inhalers (U01): Metered dose inhalers (MDIs) consist of a formulation, with active ingredient(s) and possibly excipients in a propellant contained in a pressurized canister, and are aerosolized using a valve fitted to an actuator. Dose counters/indicators are an add-on mechanism to MDIs and aid in tracking the number of doses remaining in the canister. According to the Guidance for Industry: Integration of Dose-Counting Mechanisms into MDI Drug Products (March 2003), in vitro testing (simulating both actual-use and misuse) and in-use studies are recommended to be conducted in order to establish functionality, reliability, and accuracy of dose counters/indicators in MDIs. The in-use studies supplement the in vitro testing and provide information regarding any problems when the dose counter/indicator is used in a clinical setting. The potential failure modes reported for MDI dose counters/indicators include, but are not limited to, undercounting, over counting and count(s) upon dropping.In general, in vitro robustness studies for MDIs include, but are not limited to, effect of dropping, shaking, exposure to temperature extremes, shipping, and storage under accelerated conditions on MDI drug product performance. Due to limited information available on the relevance of these in vitro robustness studies to clinical outcomes, it may be difficult to predict the failure modes of dose counters/indicators in MDIs under actual-use conditions. Therefore, there is a need to develop new or improve the existing in vitro studies used to assess robustness of dose counters/indicators in MDIs to better predict occurrence and type of failure for dose counters/indicators under actual-use conditions.The goal of this study is to develop clinically relevant in vitro studies to assess robustness of dose counters/indicators in MDIs representing the actual-use/misuse conditions. This study will consist of three phases. Phase 1: Select two commercially available MDIs with dose counters/indicators. Phase 2: Design new or modify existing in vitro methods and conduct in vitro robustness studies for the MDIs selected in Phase 1. Identify the intensity of in vitro tests needed to cause product failures, while ensuring that the proposed tests are predictive and relevant to actual-use conditions. Phase 3: Validate the proposed in vitro robustness studies using other marketed MDIs with dose counters/indicators.
Federal Grant Title: Development of realistic in vitro studies to assess robustness of dose counters/indicators in metered dose inhalers (U01)
Federal Agency Name: Food Drug Administration
Grant Categories: Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-14-025
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jun 2, 2014
Original Application Deadline: Jun 2, 2014
Posted Date: Apr 18, 2014
Creation Date: Apr 17, 2014
Archive Date: Jul 2, 2014
Total Program Funding: $500,000
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award: $450,000
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Others (see text field entitled "Additional Information on Eligibility" for clarification)
State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
County governments
Special district governments
City or township governments
Public housing authorities/Indian housing authorities
Independent school districts
Public and State controlled institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
For profit organizations other than small businesses
Additional Information on Eligibility
Foreign Institutions are eligible to apply
Link to Full Grant Announcement
Full Announcement
Grant Announcement Contact
Martin Bernard Grants Management Specialist Phone 240-402-7564
FDA OFFICE

Food & Drug Administration 301-443-5869
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