相关实验视频

Updated: Jun 19, 2025

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
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Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

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释放对后审批变更的依赖的力量:与48个国家监管机构一起的旅程

Francesca Mangia1, Yameng Melly Lin2, John Armando3

  • 1F.Hoffmann-La Roche, Grenzacherstrasse 124, Basel, 4058, Switzerland. francesca.mangia@roche.com.

Therapeutic innovation & regulatory science
|July 24, 2024
PubMed
概括

一个使用监管依赖于批准后变更 (PAC) 的试点项目旨在加快全球药物批准并确保持续的药物供应. 这一举措简化了关键制造变更的审查过程,使全球患者受益.

关键词:
收 收 收 收 收 收审批后的变化 审批后的变化需要依靠的是依靠.透明度 透明度 透明度

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