Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives

The National Institute for Pharmaceutical Technology and Education (NIPTE) was formed in June 2007 as an independent nonprofit organization by 11 major US universities. Approximately 30 faculty members from the member universities* are collaborating on various NIPTE projects, as are scientists from Pfizer (New York), Baxter (Bloomington, IN), Abbott Laboratories (Abbott Park, IL), and the US Food and Drug Administration. The institute s research agenda, aimed at improving the quality of drugs and pharmaceutical products, includes the following:

Developing an understanding of factors affecting variability in drug development, scale-up, quality, and manufacturing
Improving the scientific basis for understanding the behavior of pharmaceutical materials and the requisite processing steps
Developing tools to predict product performance early in the development process as well as strategies to allow rapid design and scale-up of manufacturing processes
Reducing risk and time-to-market for new drugs.