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Basic requirements on post-marketing clinical re-evaluation of Chinese medicine and phase Ⅳ clinical trials
Pages: 2764-2767
Year: Issue:  20
Journal: China Journal of Chinese Materia Medica

Keyword:  中药 上市后再评价 Ⅳ期临床试验;
Abstract: 鉴于药品上市前临床试验获得的药品安全性和有效性数据的局限性,开展中药上市后临床再评价是非常必要的。该文讨论中药上市后临床再评价与Ⅳ期临床试验的共同点与区别;根据国内外相关法规,结合专家建议,提出中药上市后临床再评价的基本要求和建议;讨论Ⅳ期临床试验在适应证范围、设计方法、病例入选和排除标准、样本含量等方面的具体要求。
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