Digital Tools-Regulatory Considerations for Application in Clinical Trials.

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作者： Lian,Gelis ^[1] ; Isabelle,Stoeckert ^[2] ; Hans-Peter,Podhaisky ^[3]

作者单位： Bayer AG, Research & Development, Pharmaceuticals, Project Management 1, Wuppertal, Germany. ^[1] Bayer AG, Research & Development, Pharmaceuticals, Regulatory Affairs, EMEA, Wuppertal, Germany. ^[2] Bayer AG, Research & Development, Pharmaceuticals, Regulatory Affairs, MD, Berlin, Germany. hans-peter.podhaisky@bayer.com. ^[3]

关键词 DDT DHT Digital tool Drug development SaMD

主题词美国(United States);美国食品和药物管理局(United States Food and Drug Administration);药物评价(Drug Evaluation);制药工业(Drug Industry);软件(Software)

DOI 10.1007/s43441-023-00535-z

PMID 37195515

发布时间 2024-02-09

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Therapeutic innovation & regulatory science

2023年57卷4期

769-782页

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Digital Tools-Regulatory Considerations for Application in Clinical Trials.

Therapeutic innovation & regulatory science

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Digital Tools-Regulatory Considerations for Application in Clinical Trials.

Therapeutic innovation & regulatory science

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Therapeutic innovation & regulatory science

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