试验设施管理:新时代的责任和范例

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY Journal of pharmacological and toxicological methods Pub Date : 2024-04-16 DOI:10.1016/j.vascn.2024.107505
M. Breda , M. Pilla , M. Brazzarola , B. Vaccarini
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引用次数: 0

摘要

GLP 试验设施管理是指对按照 GLP 法规开展研究的设施进行适当的管理和组织。根据 GLP 原则,试验设施管理(TFM)负责一系列广泛的任务和职责,以确保试验设施顺利、高效地运行。与 GLP 实施初期相比,试验设施管理机构的运作框架无疑要复杂得多,而且从科学和技术角度来看,未来几年也不可能有任何变化。从科学技术的角度来看,有几个方面已经发生了变化,我们知道创新是非常迅速的。综上所述,有必要对专题工作队的职能进行重大调整。
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Test facility management: Responsibilities and paradigms of a new era

GLP test facility management refers to the proper management and organization of a facility that conducts studies according to GLP regulations. Compliance with GLP regulations is necessary for data generated in such facilities to be accepted by regulatory authorities.

According to GLP Principles, Test facility management (TFM) is responsible for a wide range of tasks and responsibilities to ensure the smooth and efficient operation of the facility. The framework in which the TFM operates within the Test Facility is certainly much more complex than in the early days of the GLP, and moreover it is unlikely that anything will change from a scientific and technological point of view in the years to come. Several aspects have changed from a scientific and technological point of view, and we know that innovation is very rapid. From the above considerations emerges the need for a major change in the performance of the TFM's role.

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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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