Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle
Statisticians at Pfizer who support Chemistry, Manufacturing, and Controls (CMC), and Regulatory Affairs (Reg CMC) have developed many statistical R-based computational tools to enable high efficiency, consistency, and fast turnaround in their routine statistical support to drug product and manufacturing process development. Most tools have evolved into web-based applications for convenient access by statisticians and colleagues across the company. These tools cover a wide range of areas, such as product stability and shelf life or clinical use period estimation, process parameter criticality assessment, and design space exploration through experimental design and parametric bootstrapping. In this article, the general components of these R-programmed web-based computational tools are introduced, and their successful applications are demonstrated through an application of estimating a drug product shelf life based on stability data.
KeywordsStatistical computing Web based tool R programming Regression analysis Design of experiment
The authors acknowledge Kimberly Vukovinsky, Robert J. Timpano, and colleagues in Pharmaceutical Science and Manufacturing Statistics group at Pfizer for their generous support of evaluating and commenting the web-based applications.
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