Food and Drug Administration

Description

The goal of this project is to develop a process simulation and modeling platform for integrated pharmaceutical manufacturing processes. Specifically, the project will focus on manufacturing processes for solid based drug products which comprise the majority of pharmaceutical products. The tools developed during this project will be used to facilitate the risk assessment of manufacturing processes and control strategies and to identify critical material and process attributes through sensitivity analysis. The project will advance the understanding of how raw material attributes and process parameters affect quality of the final drug product.

Who can apply

• 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)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Lisa Ko <br/>Grants Management Specialist <br/>
lisa.ko@fda.hhs.gov