PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Topics Review
Data utilization and Data-driven oriented reforms in pharmaceutical development and manufacturing
Akito DAIBA
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2022 Volume 24 Issue 1 Pages 1-9

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Abstract

In the recent years, there have been an increasing number of reports on the digital transformation cases in the pharmaceutical industry. However, those reports tend to focus on discovery research, marketing or new health care approach using a real-world data set rather than pharmaceutical development and manufacturing.

In this article, challenges relative to effective use of digital technology in the pharmaceutical development and manufacturing are discussed. Also feasibility of effective use of data for knowledge management and work process innovation is assessed. Furthermore, based on the feasibility assessment, impact of data-driven work process transformation is presented.

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© 2022 Parenteral Drug Association Japan Chapter
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