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首页> 外文期刊>Journal of pharmaceutical sciences. >CLINICAL TRIALS AND TRANSLATIONAL MEDICINE COMMENTARIES Lead PK Commentary: Predicting Human Pharmacokinetics
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CLINICAL TRIALS AND TRANSLATIONAL MEDICINE COMMENTARIES Lead PK Commentary: Predicting Human Pharmacokinetics

机译：临床试验和翻译医学评论铅PK评论：预测人类药代动力学

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摘要

Selecting the best compounds, often from among many, to bring forward for evaluation in humans is a difficult and challenging task. Recognizing this problem, the Pharmaceutical Research Manufacturers Association (PhRMA) established a Pharmaceutical Innovations Steering Committee (PISC) with the aim of improving the chances of success. In addition to the two task forces focusing on safety and efficacy, another focused on prediction of human pharmacokinetics (PK). Published in this issue of the Journal, in the form of five papers, is the outcome of the research undertaken by this last group. Although there have been substantial improvements in our understanding of factors controlling the PK of a compound, such that it is often now not the primary reason for failure during clinical drug development, there is still a great need to improve our prediction methods for several reasons.
机译：通常，从众多化合物中选择最佳化合物以进行人体评估是一项艰巨而艰巨的任务。认识到这个问题，药物研究制造商协会（PhRMA）成立了药物创新指导委员会（PISC），旨在提高成功的机会。除了两个工作组专注于安全性和有效性外，另一个工作组专注于人类药代动力学（PK）的预测。这最后一组的研究结果以五篇论文的形式在本期《期刊》上发表。尽管我们对控制化合物PK的因素有了实质性的改善，以至于现在它通常不是临床药物开发过程中失败的主要原因，但出于多种原因，仍然非常需要改进我们的预测方法。

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