CFD Models to aid the development of generic inhalation products

Current US Food and Drug Administration product specific guidance (PSG) bioequivalence (BE) recommendations for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically use a weight-of-evidence approach that includes in vitro studies, an in vivo pharmacokinetics

credit:


(PK) study, and either an in vivo pharmacodynamics (PD) or comparative clinical endpoint (CCEP) study.

To produce a generic MDI or DPI that is capable of passing all of these recommended studies, it would be useful to have an enhanced understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue.

Computational fluid dynamics (CFD) is a technique capable of predicting these relationships between in vitro study metrics and regional lung deposition.

The purpose of this grant announcement is to use CFD to produce verified and validated predictions of regional lung deposition for at least one currently marketed MDI or DPI in human upper and lower airways.

Once predictions are appropriately verified and validated using either in vitro or in vivo data, a parameter sensitivity analysis will be conducted to assess the biopredictive capabilities of relevant in vitro studies.

For DPIs, discrete element modeling (DEM) may be considered as a means for predicting the effects of agglomeration and deagglomeration of carrier-active pharmaceutical ingredient combination particles on regional deposition and the relationships of those phenomena with APSD.

For MDIs, it is preferred that formulations considered include at least three components.
Related Programs

Food and Drug Administration Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: Food and Drug Administration

Estimated Funding: $80,000


Who's Eligible


Relevant Nonprofit Program Categories



Obtain Full Opportunity Text:
http://alaska.fws.gov/fisheries/fieldoffice/fairbanks/subsistence/r_m_fund.htm

Additional Information of Eligibility:
• Businesses and government entities do not qualify.

Applicants must be individuals or registered NGOs.

• Recipients may demonstrate their commitment by either contributing to the project financially, or providing labor or supplies to carry out the project.

Cost-sharing is not required but encouraged.

All applicants must display sound management in the form of financial and administrative procedures that protect against waste, fraud, and abuse.

Full Opportunity Web Address:
http://alaska.fws.gov/fisheries/fieldoffice/fairbanks/subsistence/r_m_fund.htm

Contact:


Agency Email Description:
shashi.malhotra@fda.hhs.gov

Agency Email:


Date Posted:
2021-05-25

Application Due Date:


Archive Date:
2021-05-26


Dsenyo, founded and designed by Marissa Perry Saints, seeks to help women and artisans working their way out of poverty. Dsenyo is an ethical fashion company that operates as a social enterprise that supports living wage opportunities for workers in Malawi, Africa.




Not for Profit Jobs in Nebraska

  Executive Director Jobs
  Substance Abuse Jobs
  Program Director Jobs
  Executive Director Jobs
  Social Services Jobs





More Federal Domestic Assistance Programs


Department of Defense Appropriation Act of 2003 | Fort Huachuca Environmental Training  | Building Capacity of the Public Health System to Improve Population Health through National, Non-Profit Organizations- financed in part by Prevention and Public Health Funds (PPHF)  | Farm Business Management and Benchmarking Competitive Grants Program | Highlands Conservation  |  Site Style by YAML | Grants.gov | Grants | Grants News | Sitemap | Privacy Policy


Edited by: Michael Saunders

© 2004-2022 Copyright Michael Saunders