对于显著未满足的临床需求(unmet medical need)而言,第一个出现的药物,具有巨大的优势和机会。西达苯胺从IND到上市仅用了七年时间,并且完成II其临床便获批上市,正应验了这一...
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Continuous dopaminergic drug delivery is an unmet medical need in advanced Parkinson's disease.
晚期帕金森患者中持续多巴胺能药物应用不能满足治疗需要。
The program allows the FDA to approve a drug to treat serious diseases with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit.
该程序允许FDA根据一项被认为能够可靠预测临床疗效的(试验)终点来批准用于治疗目前医学无法满足的严重疾病的药物。
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