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首页> 外文期刊>Journal of pharmaceutical sciences. >Drug delivery trends in clinical trials and translational medicine: evaluation of pharmacokinetic properties in special populations.
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Drug delivery trends in clinical trials and translational medicine: evaluation of pharmacokinetic properties in special populations.

机译：临床试验和转化医学中的药物输送趋势：评估特殊人群的药代动力学特性。

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In spite of the recent advances in technology to optimize the absorption, distribution, metabolism and elimination (ADME) properties of new and promising medicinal products to reduce clinical failures, the investigation of drug disposition in the pediatric and elderly populations continues to be under evaluated. With the increasing prevalence of aging populations world-wide, there is a growing concern from health care providers, regulators and the general public that drug delivery is still less than optimal for the vulnerable patient populations likely to be more sensitive to adverse effects of the new investigational drugs. This review of the ClinicalTrials.gov database revealed a rapidly increasing number of clinical trials and a trend towards wider inclusion criteria of the elderly population in clinical trials over the past 10 years. However, when we summarized trials by drug delivery, biological platforms, and disease categories, less than 10% of these trials included pharmacokinetic evaluation in elderly subjects greater than 65 years of age, and less than 4% included pharmacokinetic evaluation in children less than 17 years of age. Across the various disease areas, the percentage of trials that included pharmacokinetic evaluation in the children and elderly has remained low and is consistently less than the studies that included the younger 18 to 65 age group. Therefore, it is not known whether the right information is being generated from the growing number of clinical trials to guide optimal dosing recommendations in special patient populations.
机译：尽管最近在优化新的和有前景的药物的吸收，分布，代谢和消除（ADME）特性以减少临床失败的技术方面取得了进步，但对儿童和老年人群中药物处置的研究仍在评估中。随着世界范围内老龄化人口的日益增加，医疗保健提供者，监管者和公众越来越关注的是，对于易受伤害的患者群体而言，药物输送仍不是最佳选择，可能对新药的不良反应更加敏感研究药物。对ClinicalTrials.gov数据库的审查显示，过去10年中，临床试验的数量迅速增加，并且老年人群纳入临床试验的标准越来越广泛。但是，当我们按给药方式，生物学平台和疾病类别总结试验时，这些试验中只有不到10％包括对65岁以上的老年受试者进行药代动力学评估，而只有不到4％的研究包括17岁以下儿童的药代动力学评估。岁。在各个疾病领域，包括儿童和老年人药代动力学评估在内的试验百分比一直很低，并且始终低于18至65岁年龄段的研究。因此，尚不清楚是否从越来越多的临床试验中获得了正确的信息，以指导特殊患者群体的最佳用药建议。

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