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Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01)

Post Date

July 18th 2011

Application Due Date

August 15th 2011

Funding Opportunity Number


CFDA Number(s)


Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Business and Commerce
Consumer Protection

Number of Awards


Eligibility Categories

County Governments
City or Township Governments
Independent School Districts
Federally Recognized Native American Tribal Governments
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
For-Profit Organizations (Except Small Businesses)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.


  • Estimated Total Funding:


  • Award Range:

    $1 - $160000

Grant Description

The project highlights the following important areas in chemistry, manufacturing and controls of dry powder inhaler (DPI) drug products: -Controlling the manufacturing of API crystals in order to obtain micronized API materials with low variability and consistency; -Defining the critical quality attributes of the API crystals that must be measured and controlled to ensure quality in the final drug product; -Emphasizing the relationship between the properties of the API crystals and the quality of micronized API materials to be in included in the final drug product; -Exploring the effects of post-micronization relaxation of micronized API on product performance, with an aim to understand the requirements for laagering and quarantining of micronized API materials.

Contact Information

  • Agency

    Department of Health and Human Services

  • Office:

    Food and Drug Administration

  • Agency Contact:

    Lisa Ko
    Grants Management Specialist

  • Agency Mailing Address:

  • Agency Email Address:

  • More Information:

    NIH Guide Announcement Link

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