OpportunityTitle: Quality by Design for Orally Inhaled Drugs: Chemistry, Manufacturing, and Controls (U01)
AdditionalInformationOnEligibility: Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.  Foreign (non-U.S.) components of U.S. Organizations are allowed.
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.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist