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免疫激活产品在瘤学中的第一次人体剂量选择的药理动力学模型

Haleh Saber1, Matthew D Thompson1, John K Leighton1

  • 1US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Oncologic Diseases, 10903 New Hampshire Ave, Silver Spring, MD, 20903, United States.

Regulatory toxicology and pharmacology : RTP
|April 1, 2024
PubMed
概括

简单的药理动力学 (PK) 建模可用于选择免疫瘤学药物的首次人体 (FIH) 剂量. 仔细选择变量至关重要,特别是对于CD3结构,以确保安全和最佳的FIH剂量选择.

关键词:
美国食品药品监督管理局 FDA FDA人类首次使用剂量.激活免疫系统的激活免疫瘤学 免疫瘤学玛贝尔是什么意思 玛贝尔是什么意思建模建模模型是什么在瘤学瘤学.预计的PK预计PK

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