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CFD Models to aid the development of generic inhalation products
Rolling Submissions
HHS-FDA
Description
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 (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...
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Expected Number of Awards
2
Eligible Applicants
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For-profit organizations other than small businesses
- Small businesses
Funding Type
Grant
Categories of Funding Activity
- Consumer Protection
- Food and Nutrition
- Health
Opportunity Type
Discretionary
Grantor Contact Information
shashi.malhotra@fda.hhs.gov
Grantor Email
shashi.malhotra@fda.hhs.gov
Other Grantor Informaiton
Shashi Malhotra Grants Management Specialist
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