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首页> 外文期刊>International journal of pharmacokinetics. >Large molecules with large pharmacokinetic variability: progress in pursuit of key considerations for intersubject variability
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Large molecules with large pharmacokinetic variability: progress in pursuit of key considerations for intersubject variability

机译：大分子与大的药代动力学可变性:进步的关键考虑主体的变化

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摘要

The introduction of monoclonal antibodies (mAbs) to therapeutics for targeted therapy marked a transformation in therapeutic options as well as conventional drug knowledge. This transformation in therapeutics is akin to the 'second curve' described by Charles Handy [i] in his ideas on reinventing society and businesses. While progressing in the path of that second curve we have many opportunities and challenges. One of the challenges is understanding the variable pharmacokinetics (PK) and response to mAbs in different individuals. The PK of mAbs have been well described in several reviews [2-6] and it is evident from these reviews that significant intersubject variability in PK and response is expected with mAbs. A recent review focused on the likely extent of the variability and areas within the adsorption, metabolism, distribution and elimination (ADME) processes that can potentially account for the observed intersubject variability in the PK [7]. It is clear that a multitude of different factors can account for the PK differences in individuals. The challenge is in identifying those variables that have a profound effect on PK variability in individuals and, thus, would be useful for consideration when deciding on mAb doses for individual patients.
机译：采用单克隆抗体(mab)为靶向治疗是治疗转型以及治疗选项传统的药物知识。在治疗类似于“第二曲线”所描述的查尔斯•汉迪(我)在他的想法改造社会和企业。我们前进的道路,第二曲线有很多机遇和挑战。是理解变量的挑战马伯药物动力学(PK)和响应不同的个体。好几个评论[2 - 6]中描述它从这些评论明显重要主体间变异性在PK和响应与马伯预期。可能的变化和地区在吸附、新陈代谢,分布和消除(ADME)过程可能观察到的主体变化在PK[7]。许多不同的因素可以解释PK的个体的差异。在确定这些变量对PK可变性在个体产生深远的影响,因此,将审议时有用对个别患者决定马伯剂量。

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