药物体内与体外研究评价方法及其相互关系(5)
作者:佚名; 更新时间:2014-10-17
忽视,更加说明体内体外研究的重要性。

  体内-体外相关性就是将药物剂型在体外的变化情况与其在体内的生物药剂学一药动学变化情况关联起来,它是体外溶出度和体内生物利用度参数的函数。也就是说研究某个药物制剂的体内-体外相关性的目的,在于建立一个可以说明生物利用度的体外质量标准,和用作制剂批量生产时的质控指标。即便当前由于体外溶出度测定与体内生物利用度评价存在一定的问题,但本作者相信随之科技的进步,体外溶出度测定试验在不久的将来在模拟体内行为方面会发挥更大的作用。

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