国际肾脏病学会首份关于转化肾脏学预临床动物研究的共识指南。
International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology.
发表日期:2023 Mar 27
作者:
Masaomi Nangaku, A Richard Kitching, Peter Boor, Alessia Fornoni, Jürgen Floege, P Toby Coates, Jonathan Himmelfarb, Rachel Lennon, Hans-Joachim Anders, Benjamin D Humphreys, Fergus J Caskey, Agnes B Fogo,
来源:
Disease Models & Mechanisms
摘要:
动物模型的临床前试验是早期药物开发的关键步骤。因此,国际肾脏学会召开了一次共识会议,与全球肾脏医学专家进行研究,探讨最佳翻译动物研究管理以开发治疗肾脏疾病的新药物,会议名为“转化;新药物翻译肾脏医学科学”。会议包括以下各个主题:(一)疾病模型的选择;(二)药代动力学;(三)晚期临床前模型的介入;(四)动物的选择;(五)统计力量;(六)器官模型和器官芯片模型;以及(七)结果报告。这是有关最佳翻译动物研究管理以开发治疗肾脏疾病的新药物的首次指南。这些建议旨在加速开发治疗肾脏疾病的新药物,并改善患有多种肾脏疾病患者的预后和生活质量版权所有©2023年国际肾脏学会。保留所有权利。
Preclinical tests in animal models are key steps in early drug development. Consequently, the International Society of Nephrology held a consensus meeting that connected experts in the global kidney community in order to provide guidance on optimal management of translational animal studies for the development of new drugs to treat kidney disease, entitled "TRANSFORM; TRAnslational Nephrology Science FOR new Medications." The meeting covered various themes, including the following: (i) selection of disease model; (ii) pharmacokinetics; (iii) interventions in late preclinical models; (iv) choice of animal; (v) statistical power; (vi) organoids and organ-on-a-chip models; and (vii) reporting of results. This guidance is the first to be provided on the optimal conduct of translational animal studies for the development of new drugs to treat kidney disease. These recommendations are designed to accelerate development of new drugs for efficacious treatment of kidney diseases, and to improve the prognosis and quality of life of patients with a variety of kidney diseases.Copyright © 2023 International Society of Nephrology. All rights reserved.