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Updated: May 8, 2025

Author Spotlight: Addressing Regulatory Gaps in Molecular Studies by Quantifying Viral Vectors in Complex Matrices
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2009年至2023年在欧盟授权的先进疗法药品的风险最小化措施:一项跨部门研究

Sharon C M Essink1,2, Inge M Zomerdijk2, Sabine M J M Straus2,3

  • 1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.

Drug safety
|April 10, 2025
PubMed
概括

先进治疗药物 (ATMP) 需要积极的风险管理. 大多数在欧盟授权的ATMP使用额外的风险最小化措施 (aRMM),主要是教育材料,以解决长期影响和程序并发症等安全问题.

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