2015 儿童抽动障碍中药新药临床试验设计与评价技术指南

2015-12-10 中华中医药学会儿科分会临床评价学组 药物评价研究.2015,38(6):589-895.

本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了儿童抽动障碍中药新药临床试验的设计与评价技术要点,期望能为申办者与研究者在临床试验方案设计中提供指导。

中文标题:

2015 儿童抽动障碍中药新药临床试验设计与评价技术指南

发布日期:

2015-12-10

简要介绍:

本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了儿童抽动障碍中药新药临床试验的设计与评价技术要点,期望能为申办者与研究者在临床试验方案设计中提供指导。

拓展指南:儿童抽动障碍相关指南:

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2015 儿童抽动障碍中药新药临床试验设计与评价技术指南
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    2023-05-27 ms7000000179686827 来自山东省

    好好学习天天向上

    0

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    2022-01-04 微笑人参

    好好学习,天天向上。

    0

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    2021-06-19 微笑人参

    希望多关注,想多学习这类知识

    0

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    2016-09-11 doctorJiangchao

    继续学习

    0

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    2016-09-11 doctorJiangchao

    继续关注

    0