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学习笔记:抗体药物的非临床研究概述

  • 2026-01-11 12:39:08
学习笔记:抗体药物的非临床研究概述
药物的非临床药理毒理研究贯穿整个声明研发周期，包括药物发现阶段的药效药代评价，申报临床前的药理毒理，临床阶段的药理毒理研究以及上市后可能因为变更等原因进行的药理毒理研究。
以抗体药物为例，临床前以及临床阶段需要进行的非临床研究以及各模块关注点见下图：
1. 关于相关种属的选择。
一般要求两个种属，啮齿类（常规大鼠，小鼠），非啮齿类（常规食蟹猴，比格犬），无相关种属时，首选转基因动物（常规小鼠），无转基因模型时，考虑替代分子。
2. 关于常规药物的试验周期。
具体要求见下图。另外FDA在2025.12发布了《Monoclonal Antibodies：Streamlined Nonclinical Safety Studies》指南草案的思考，指出对于单抗类药物，特定情况下可以免于开展3个月以上毒理试验或者采用3个月毒理学研究数据+WoE分析替代6个月长毒研究。目前该指南仍是草案阶段，具体是否能实施让我们拭目以待。
3. 关于临床起始剂量的估算方法：
关于起始剂量的估算方法，一般包括NOAEL法（毒理试验剂量）、PAD（药理学活性）法、MABEL法（最低预期生物剂量）三种，下方为对应的决策树。一般而言，常规药物采用NOAEL法推算MRSD， 免疫激活剂或其他风险较高的分子采用MABEL法推算。
4. 关于注册资料撰写
总体而言，非临床研究内容相对比较固定的，目前国内非临床研究机构在常规试验方面均比较成熟。虽然是差不多类型的试验，但是在实践中发现最终呈现在申报资料中大有不同。有的重点突出，一下子就能看到最关键的信息，有的可能仅是对试验的陈述。那么在递交IND/BLA资料时，如何让老师快速看到自己想看的，增加审评老师的好感呢？
除了上图绿框中的关注点外，在CTD资料2.4非临床综述总结部分，建议明确NOAEL，并进行风险分析并提供对应的措施。例如靶点特异性和脱靶风险，对关键风险信号进行分析（总结动物毒性的可逆性、剂量依赖性，提出临床监测指标（如皮肤刺激性、细胞因子水平、免疫毒）），模型局限性（若仅一种相关动物模型可用，或使用同源分子需提供充分证据）以及临床相关性分析（基于动物数据推算人体起始剂量（NOAEL法/PAD法/MABEL法），确定安全范围（Safety Margin），并于临床剂量对比预测潜在临床风险（如输注反应、细胞因子释放综合征、靶点相关毒性），并关联至临床试验监测计划（如特定器官功能检测、免疫原性监测频率）。
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  135. /yingpanguazai/ssd/ssd1/www/no.67808.cn/vendor/topthink/framework/src/think/contract/TemplateHandlerInterface.php ( 1.60 KB )
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  139. /yingpanguazai/ssd/ssd1/www/no.67808.cn/runtime/temp/6df755f970a38e704c5414acbc6e8bcd.php ( 12.06 KB )
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  1. CONNECT:[ UseTime:0.000553s ] mysql:host=127.0.0.1;port=3306;dbname=no_67808;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000611s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000334s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000292s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000507s ]
  6. SELECT * FROM `set` [ RunTime:0.000248s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000505s ]
  8. SELECT * FROM `article` WHERE `id` = 459232 LIMIT 1 [ RunTime:0.000387s ]
  9. UPDATE `article` SET `lasttime` = 1768118332 WHERE `id` = 459232 [ RunTime:0.005671s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.004640s ]
  11. SELECT * FROM `article` WHERE `id` < 459232 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000442s ]
  12. SELECT * FROM `article` WHERE `id` > 459232 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.001707s ]
  13. SELECT * FROM `article` WHERE `id` < 459232 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.004024s ]
  14. SELECT * FROM `article` WHERE `id` < 459232 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.004643s ]
  15. SELECT * FROM `article` WHERE `id` < 459232 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.007121s ]
0.099873s