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Updated: Feb 26, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Published on: September 20, 2019

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临床试验数据集规范的必要性,以支持临床药理学对免疫性进行审查

Sophie Shubow1,2, Mohsen Rajabi Abhari3,4, Anh Ta3,5

  • 1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Sophie.Shubow@fda.hhs.gov.

The AAPS journal
|February 24, 2026
PubMed
概括

评估抗药抗体 (ADA) 反应对于生物许可申请 (BLA) 至关重要. 许多BLA面临数据集问题,推迟审查. 针对免疫性数据的标准化规范可以提高监管效率.

关键词:
这是CDISC的CDISC.临床药理学临床药理学数据统一和数据协调.免疫性 免疫性 免疫性药物动力学 药物动力学

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