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Inhaled efficacious dose translation from rodent to human: A retrospective analysis of clinical standards for respiratory diseases
Pharmacology & Therapeutics ( IF 12.0 ) Pub Date : 2017-04-23 , DOI: 10.1016/j.pharmthera.2017.04.003
J.E. Phillips

Clinical pharmacologists and toxicologists are often faced with predicting equivalent dosages for humans from biological observations in laboratory animals. Allometric scaling has been used extensively as the basis for extrapolation of drug dosage that might be expected to produce the equivalent biological effects. Allometry is the study of size and its consequences and it is based on the anatomical, physiological, and biochemical similarities between animals. In this review, retrospective analyses have been performed based on data reported in the literature in an attempt to determine the utility of allometric scaling for human dose projections from pre-clinical data for compounds that are delivered by inhalation. The limited pre-clinical efficacy data available on inhaled drugs that are also used clinically supports the current method of scaling using a fixed allometric exponent of 0.67. An example of the utility of the human inhaled dose projections for planning inhaled toxicology studies is also presented.



中文翻译:

从啮齿动物到人类的吸入有效剂量转化:呼吸系统疾病临床标准的回顾性分析

临床药理学家和毒理学家经常面临着根据实验动物的生物学观察预测人类等效剂量的问题。异速代谢定标已被广泛用作推断可能产生同等生物学效应的药物剂量的基础。异速测量法是对大小及其后果的研究,它基于动物之间的解剖,生理和生化相似性。在这篇综述中,已经根据文献中报道的数据进行了回顾性分析,以试图从通过吸入传递的化合物的临床前数据确定人体剂量预测的异度缩放比例的效用。在临床上也使用的可吸入药物可获得的有限的临床前功效数据支持了使用固定变构指数为0.67的当前缩放方法。还提供了人类吸入剂量预测在规划吸入毒理学研究中的效用的一个例子。

更新日期:2017-04-23
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