Development of Clinically Relevant in Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis

The summary for the Development of Clinically Relevant in Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis 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 Clinically Relevant in Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis: For orally inhaled drug products (OIDPs), mouth-throat (MT) region behaves as a physiological filter that prevents significant fraction of inhaled drug from reaching the lungs. Hence, use of the models representing morphological features of MT region could help predict the drug loss in the MT region, and hence provide better predictability of lung deposition. Such realistic MT models, coupled with cascade impactors, could be used for characterization of aerodynamic particle size distribution (APSD), and can therefore be used as a pharmaceutical development tool for OIDPs. However, there are some challenges in adopting these modified cascade impactor methods. Although, several MT models have been proposed in the literature, with different geometries that produce different deposition patterns, there is lack of availability of the standardized MT model(s). Moreover, it has been demonstrated that coupling these MT models with realistic inhalation maneuvers in an impactor assembly can further improve in vivo predictability of these methods. However, there are no standardized inhalation maneuvers available for APSD characterization of different OIDPs. In addition, very limited information is available on the validity of the proposed MT models in terms of their in vivo predictability. Therefore, in order to build a predictive in vitro method for characterization of APSD, it is important to address the issues discussed above with aim of identifying optimal MT models that produce acceptable in vitro-in vivo correlation. ObjectivesThe goal of this project is to investigate if realistic physical MT models provide better predictability over pharmaceutical induction port assembly, for APSD characterization of OIDPs. Because there are different MT models proposed in the literature, in vivo predictability of several pre-screened MT models will be evaluated under different flow rate conditions, to select the optimal model(s). Upon successful completion, this research will provide a more realistic APSD characterization method that can be used as a pharmaceutical development tool in the early stages of OIDP development. Detailed DescriptionA predictive in vitro method will be developed to study the aerodynamic particle size distribution of the aerosolized drug particles. The study will consist of four phases. Phase 1: Selection of realistic MT models based on reported in vivo predictability and production/reproduction feasibility.Phase 2: Selection of representative OIDPs on the market for in vitro APSD evaluation using selected MT models. Phase 3: APSD characterization of the selected OIPDs products using cascade impactors USP apparatus 1 and 6 assembled with the selected throat models as well as USP induction port, under different flow rate conditions. Phase 4: Assessment of in vitro-in vivo correlation for each MT models and selection of optimal model/models.
Federal Grant Title: Development of Clinically Relevant in Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis
Federal Agency Name: Food Drug Administration
Grant Categories: Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-14-022
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jun 3, 2014
Original Application Deadline: Jun 3, 2014
Posted Date: Mar 31, 2014
Creation Date: Apr 1, 2014
Archive Date: Jul 3, 2014
Total Program Funding: $1,000,000
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award: $450,000
Expected Number of Awards: 5
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Others (see text field entitled "Additional Information on Eligibility" for clarification)
State governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Individuals
Private institutions of higher education
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
City or township governments
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Small businesses
County governments
Additional Information on Eligibility
Foreign Recipients
Link to Full Grant Announcement
How to Apply
Grant Announcement Contact
Gladys Melendez-Bohler Grants Management Specialist Phone 301-827-7175
FDA Office

Food & Drug Administration 301-443-5869
Similar Government Grants
Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical...
Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biologic...
Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade ...
Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) ...
Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including ...
Support for Small Scientific Conference Grant Program
Cooperative Agreement to Support the World Health Organization (WHO) International Program...
Clinical Studies of Safety and Effectiveness of Orphan Products
More Grants from the Food Drug Administration
NARMS Cooperative Agreement Program to Enhance and Strengthen Antibiotic Resistance Survei...
Cooperative Agreement to Support Shellfish Safety Assistance Project (U01)
Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA C...
Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food ...
National Training, Education, Extension, Outreach, and Technical Assistance Competitive Gr...

FederalGrants.com is not endorsed by, or affiliated with, any government agency. Copyright ©2007-2024 FederalGrants.com