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用力呼气量与改良欧文试验:我们在做什么?

FOB vs modified Irwin: What are we doing?

作者信息

Gauvin David V, Zimmermann Zachary J

机构信息

Neurobehavioral Sciences, Charles River Laboratories, Inc., Mattawan, MI, USA.

Neurobehavioral Sciences, Charles River Laboratories, Inc., Mattawan, MI, USA.

出版信息

J Pharmacol Toxicol Methods. 2019 May-Jun;97:24-28. doi: 10.1016/j.vascn.2019.02.008. Epub 2019 Mar 16.

DOI:10.1016/j.vascn.2019.02.008
PMID:30885703
Abstract

There is a general sentiment in the nonclinical safety assessment literature and the proponents of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), that the "Modified Irwin" and the Functional Observation Battery are distinct and unique assays for the nonclinical assessment of the central nervous system (CNS). We identify and defend the position that the Irwin screen was developed as an FOB and both terms refer to a single, unitary functional assay. In giving credit to one prominent contributor to any one significant discipline of science for a specific assay, orientation, or theory may have an exclusionary influence on the merits of other prominent contributors within the same research arena. Scientific organizations as well as journal and textbook editors have attempted to unify the nomenclature used within a scientific discipline to make the disciplines conform to non-attributional surname nomenclatures. For example, the Salk-Sabin immunization is simply referred to as the polio vaccine. The "Skinner box" is now the "operant chamber" and "Pavlovian conditioning" is now "respondent conditioning". In 1968, Samuel Irwin established an operational method of analysis used for measuring drug effects in purpose bred laboratory animals. We present and defend the view that the behavioral screening assay developed by Irwin is, for all intents and purposes, a functional observational battery (FOB). We take the position that in standardizing nomenclature without "surnames" the FOB is simply the contemporary name for the data collection system in use under the harmonized safety pharmacology guidelines.

摘要

在非临床安全性评估文献以及人用药品技术要求国际协调理事会(ICH)的支持者中,普遍认为“改良版欧文试验”和功能观察组合是用于中枢神经系统(CNS)非临床评估的独特且不同的试验。我们确定并捍卫这样一种观点,即欧文筛查最初就是作为一种功能观察组合开发的,这两个术语都指的是单一的、统一的功能试验。在将某项特定试验、方法或理论的显著贡献归功于某一重要科学学科的一位杰出贡献者时,可能会对同一研究领域内其他杰出贡献者的功绩产生排他性影响。科学组织以及期刊和教科书编辑都试图统一科学学科内使用的术语,以使各学科符合不提及姓氏的命名法。例如,索尔克 - 萨宾免疫法现在简称为脊髓灰质炎疫苗。“斯金纳箱”现在称为“操作箱”,“巴甫洛夫条件反射”现在称为“应答性条件反射”。1968年,塞缪尔·欧文建立了一种用于测量特定品种实验动物药物效应的分析操作方法。我们提出并捍卫这样一种观点,即欧文开发的行为筛查试验在所有实际用途上都是一种功能观察组合(FOB)。我们的立场是,在标准化不提及“姓氏”的术语时,功能观察组合只是统一的安全药理学指南下正在使用的数据收集系统的当代名称。

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