临床前研究中的剂量选择:跨物种剂量转换

E. Shekunova, M. Kovaleva, M. Makarova, V. Makarov
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引用次数: 7

摘要

有效转化医学的主要障碍之一是将动物研究结果转化为临床研究的挑战。科学文献主要涉及临床试验开始时(第一阶段)药物剂量的选择。适当的剂量选择对于临床前毒理学和药理学研究也是必不可少的。在计划和进行临床前研究时,将剂量从动物模型转化为人类时所使用的一些基本原则也适用于剂量的选择和论证。本文概述了临床前研究中可用于动物剂量选择和论证的主要方法,例如使用体表面积缩放法进行跨物种剂量转换。它概述了可直接根据体重换算剂量的情况。本文特别关注根据药代动力学数据的跨物种剂量转换。跨物种翻译没有放之四海而皆准的方法;剂量转换必须科学合理,考虑到试验药物的所有可用信息,即其化学结构、预期给药途径、药代动力学参数、药效学的临床前和临床数据,以及药代动力学和药效学的物种间差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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Dose Selection in Preclinical Studies: Cross-Species Dose Conversion
One of the major obstacles to effective translational medicine is the challenge of translating animal research results into clinical studies. Scientific literature mainly addresses the selection of the drug dose at initiation of clinical trials (Phase 1). Appropriate selection of doses is also essential for preclinical toxicology and pharmacology studies. Some basic principles that are used when translating dosages from animal models to humans are applicable to selection and justification of doses when planning and conducting preclinical studies. The paper provides an overview of the main methods that can be used for selection and justification of animal doses in preclinical studies, e.g. cross-species dose conversion using body surface area scaling. It summarises situations when doses may be directly converted based on body weight. The paper gives special attention to cross-species dose translation according to pharmacokinetic data. There is no one-size-fits-all approach to cross-species translation; dose conversion must be scientifically justified taking into consideration all information available on the test drug, i.e. its chemical structure, intended route of administration, pharmacokinetic parameters, preclinical and clinical data on pharmacodynamics, and inter-species differences in pharmacokinetics and pharmacodynamics.
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