Building towards Statistically-Based Pharmaceutical Quality Standards (U01)

The goal of this project is to generate data and develop a statistical sampling and analysis strategy to aid FDA/CDER policy in drafting data-based guidance in support of the use of appropriate statistical tools and standards. Specifically, the development of standards for statistical methods suitable for lot release which could be used to drive industry towards increased product and process understanding throughout the lifecycle of a product. The project will provide data, sampling and data analysis approaches to inform for the agency and the human pharmaceutical industry to advance the development of risk- and science-based standards. These projects could be split into subsets by product type, process type, manufacturing complexity and/or therapeutic index to facilitate understanding.