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Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle

  • Fasheng LiEmail author
  • Ke Wang
Conference paper
Part of the Springer Proceedings in Mathematics & Statistics book series (PROMS, volume 218)

Abstract

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.

Keywords

Statistical computing Web based tool R programming Regression analysis Design of experiment 

Notes

Acknowledgements

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.

References

  1. 1.
    US Food and Drug Administration Department of Health and Human Services. 21 CFR 11: Electronic records; electronic signatures (2017)Google Scholar
  2. 2.
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q1E: Evaluation for Stability Data (2004)Google Scholar
  3. 3.
    International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q1A (R2): Stability Testing of New Drug Substances and Products (2003)Google Scholar

Copyright information

© Pfizer, Inc. 2019

Authors and Affiliations

  1. 1.Pharmaceutical Science and Manufacturing Statistics, Pfizer Inc.GrotonUSA

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