Quantitative-Scientific Company and Product Scorecard Considerations and Modeling

Mian Yang, Purdue University

Abstract

FDA has long served as the front safeguard to the U.S. citizen public health, is also perceived as one of the world-leading drug regulators. Despite the tremendous efforts and progress have been made to promote the public health, FDA was criticized for putting the agency’s trust icon at stake and was questioned of its ability to serve the agency’s ultimate mission to protect the public. In the wake of the arousing concerns, FDA sought the transformation the oversight model of the medicinal products. One of the actions is to launch quality metrics program. However, this program has been unanimously opposed by the industry. Instead of the current conventional approach, which is constrained by the high dependence on industry cooperation, we try to explore the measurement of company and product quality risk with public domain data, try to help in visualizing quality and risk. To that end, we develop conceptual frameworks for both company and product quality, examine some of the factors (education, local authority intensity, historical inspection results, physiochemical, physiological, formulation factors, etc.), further developed a warning letter and product recall prediction model with machine learning method referenced to the data analysis outcome.

Degree

M.Sc.

Advisors

Clase, Purdue University.

Subject Area

Industrial engineering

COinS