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

RFA-FD-11-029

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Agriculture
Business and Commerce
Consumer Protection
Health

Number of Awards

1

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)
Other

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

Funding

• Estimated Total Funding:

  $160000

• 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:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov

• More Information:

  NIH Guide Announcement Link