BCS分类？欧盟审评报告中写的是BCS I类。 具体这一段落原话如下： Metformin hydrochloride (BCS class III) is freely soluble in aqueous media. Alogliptin benzoate (BCS class I) is sparingly soluble in water from pH 3-11 and particle size was demonstrated to have no effect on dissolution profile. Nonetheless, a specification for alogliptin benzoate is included to ensure the particle size distribution falls within a justified range. Excipients were chosen to maximise hardness, reduce friability, and maximise disintegration and dissolution time but also based on their compatibility with the active substances, which were also shown to be mutually stable.查看更多
怎么看FDA和CFDA批准的药物是几类?还是没有找到，抱歉，能不能截个图看看？ Label and Approval History Drug Name(s) ESOMEPRAZOLE STRONTIUM FDA Application No. (NDA) 202342 Active Ingredient(s) ESOMEPRAZOLE STRONTIUM Company ... 中国的要根据注册分类去查询，上药智网就能查到 QQ截图20160511090835.png 查看更多
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