Maximizing insights from nonclinical safety studies in the context of rising costs and changing regulations

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Donald Hodges , Michael Stonerook , Dany Salvail , Sandrine Lemouton
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引用次数: 0

Abstract

The traditional paradigm of non-rodent safety assessment studies, primarily reliant on non-human primates (NHPs) and dogs, is undergoing a transformation. During the 2023 Safety Pharmacology Society Annual Meeting, scientists from leading nonclinical contract organizations discussed how traditional IND-enabling studies can benefit from employing underutilized alternative non-rodent models, such as the swine. Swine offer a cost-effective approach to drug development and share many anatomical and physiological similarities with humans. The inclusion of non-traditional species in safety assessments, coupled with advanced measurement techniques, aids in de-risking compounds early on and adapting projects to the evolving cost landscape.

在成本上升和法规不断变化的背景下,最大限度地从非临床安全性研究中获得洞察力。
主要依赖非人灵长类动物 (NHP) 和狗进行非啮齿动物安全性评估研究的传统模式正在发生转变。在 2023 年安全药理学协会年会期间,来自领先的非临床合同组织的科学家们讨论了传统的 IND 使能研究如何从采用未充分利用的替代性非啮齿动物模型(如猪)中获益。猪为药物开发提供了一种具有成本效益的方法,并且在解剖学和生理学方面与人类有许多相似之处。将非传统物种纳入安全性评估,再加上先进的测量技术,有助于尽早降低化合物的风险,并使项目适应不断变化的成本状况。
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来源期刊
Journal of pharmacological and toxicological methods
Journal of pharmacological and toxicological methods PHARMACOLOGY & PHARMACY-TOXICOLOGY
CiteScore
3.60
自引率
10.50%
发文量
56
审稿时长
26 days
期刊介绍: Journal of Pharmacological and Toxicological Methods publishes original articles on current methods of investigation used in pharmacology and toxicology. Pharmacology and toxicology are defined in the broadest sense, referring to actions of drugs and chemicals on all living systems. With its international editorial board and noted contributors, Journal of Pharmacological and Toxicological Methods is the leading journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists.
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