数据组织在药物应用毒理学研究评价中的作用。

V C Glocklin
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引用次数: 1

摘要

FDA正在进行的新药法规重写项目的一个目标是促进和加快药物申请审查。我们认为,这可以通过改进和一致地组织提交的材料来帮助实现。因此,正在制定准则,以协助申请人编写结构良好的摘要和完整的报告章节。毒理学和相关研究的拟议格式指南并不是为了增加GLP法规已经要求的文件数量,而是为有序和连贯的提交提供一些原则,以帮助对研究内部和研究之间的各种类型的数据进行比较审查。其中某些原则可能也适用于在审查期间提交数据。计算机作为这一过程的重要甚至必不可少的辅助工具的作用是显而易见的。然而,特别重要的是,数据自动化必须足够灵活,以识别和协调数据收集和存储的不同观点,以及数据检索和组织,以有利于药物应用的科学评估。在提交计算机化毒理学数据中反复出现的问题的例子,以说明它们对药物应用的科学评估的令人沮丧或混淆的影响。
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The role of data organization in the evaluation of toxicology studies in drug application.

One goal of the FDA's ongoing New Drug Regulations rewrite project is to facilitate and expedite drug application review. We believe that this can be aided by improved and consistent organization of the submissions. Therefore, guidelines are being developed to assist applicants in preparing well-structured summaries and full report sections. The proposed format guideline for toxicology and related studies is not intended to increase the amount of documentation beyond what is already required by the GLP regulations, but rather to provide some principles for orderly and coherent submission to aid comparative review of various types of data within and between studies. Certain of these principles may also be applicable to submission of data during the IND. The computer's role as an important, even essential, adjunct to this process is clearly evident. However, it is particular important that data automation be flexible enough to recognize and reconcile the differing perspectives of data collection and storage, and data retrieval and organization to benefit scientific evaluation of a drug application. Examples of recurring problems in the submission of computerized toxicology data are presented to illustrate their frustrating or confounding effect on the scientific evaluation of drug applications.

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来源期刊
Drug Information Journal
Drug Information Journal 医学-卫生保健
自引率
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审稿时长
6-12 weeks
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