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The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management

Kabir Ahluwalia1, Michael J Abernathy2, Jill Beierle2

  • 1Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA; University of Southern California, School of Pharmacy, 1985 Zonal Ave, Los Angeles, CA 90089, USA.

Journal of Pharmaceutical Sciences
|October 5, 2021
PubMed

Keywords:
Artificial intelligenceAutomationDatabase(s)Machine learningRegulatory scienceStandards

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