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抗肿瘤治疗的免疫相关不良事件评价技术指导原则

2022-05-17 国家药品监督管理局药品审评中心(CDE) 国家药监局药审中心

肿瘤免疫治疗是当前抗肿瘤新药研发的热点,如何提高免疫相关不良事件识别、判定的科学性和稳健性,提高说明书撰写质量,切实保障患者用药安全,是目前监管方及业界亟需解决的问题。在国家

中文标题:

抗肿瘤治疗的免疫相关不良事件评价技术指导原则

发布日期:

2022-05-17

简要介绍:

   肿瘤免疫治疗是当前抗肿瘤新药研发的热点,如何提高免疫相关不良事件识别、判定的科学性和稳健性,提高说明书撰写质量,切实保障患者用药安全,是目前监管方及业界亟需解决的问题。在国家药品监督管理局的部署下,药审中心组织制定了《抗肿瘤治疗的免疫相关不良事件评价技术指导原则》

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    2022-05-18 ms1000001049221644

    学习了

    0

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    2022-05-18 Alice0218

    学习了

    0

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