[求助]NCE和NME的区别FDA专利里面有NCE（new chemical entity）和NME（new molecular entity）的区别是什么呢?感觉此概念有些模糊,国内一些文献直接将其混为一谈,在Wiki上面有如下一段话A new chemical entity (NCE) is,according to the U.S.Food and Drug Administration,a drug that contains no active moiety that has been appr
2019-11-27
[求助]NCE和NME的区别
FDA专利里面有NCE（new chemical entity）和NME（new molecular entity）的区别是什么呢?感觉此概念有些模糊,国内一些文献直接将其混为一谈,在Wiki上面有如下一段话A new chemical entity (NCE) is,according to the U.S.Food and Drug Administration,a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) ...小妹依旧没搞懂,请大侠指教
优质解答
New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act.
A new molecular entity is a drug that contains an active moiety that has never been approved by FDA or marketed in the US.
NCE和NME最大的区别在于
1.前者(NCE)不含有曾经被FDA批准的合格的或者505(b)段下正在递交或者递交了的Active moiety,后者(NME)是含有从来不曾被FDA或者美国市场批准的Active moiety.
FDA的说明定义这个Active moiety 就是the molecule or ion responsible for the physiological or pharmacological action of the drug substance.
很抱歉我虽然知道他写的是什么但是不知道怎么准确翻译给你,基本上就是生理或者药理上的有效分子或者离子.
这两个定义看上去混乱其实还是有区别的,说得更直接一点,根据这个定义NME除了可以是NCE之外也可以是biological entities.
另外最重要的一点就是NCE批下来之后政府是有五年exclusivity的,NME是没有的.
New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act.
A new molecular entity is a drug that contains an active moiety that has never been approved by FDA or marketed in the US.
NCE和NME最大的区别在于
1.前者(NCE)不含有曾经被FDA批准的合格的或者505(b)段下正在递交或者递交了的Active moiety,后者(NME)是含有从来不曾被FDA或者美国市场批准的Active moiety.
FDA的说明定义这个Active moiety 就是the molecule or ion responsible for the physiological or pharmacological action of the drug substance.
很抱歉我虽然知道他写的是什么但是不知道怎么准确翻译给你,基本上就是生理或者药理上的有效分子或者离子.
这两个定义看上去混乱其实还是有区别的,说得更直接一点,根据这个定义NME除了可以是NCE之外也可以是biological entities.
另外最重要的一点就是NCE批下来之后政府是有五年exclusivity的,NME是没有的.