医学CANDAs作为临床数据审查的监管工具

[1993] Computer-Based Medical Systems-Proceedings of the Sixth Annual IEEE Symposium Pub Date : 1993-06-13 DOI:10.1109/CBMS.1993.262998

P. Matsiras, E. Berger

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引用次数: 0

摘要

面对提交新药申请然后等待审查过程结束的任务，许多公司正在参与计算机辅助新药申请(CANDAs)，这是食品和药物管理局(FDA)和主要制药商之间的信息技术交换实验。默克加拿大医疗公司试图通过在MS Windows 3.0下开发基于pc的用户友好系统来改善这种情况，该系统有助于快速访问、审查、同化和呈现临床试验数据，用于数据的内部医学和统计审查，以及在FDA使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Medical CANDAs as a regulatory tool for clinical data review

Faced with the task of submitting new drug applications and then waiting for the review process to end, a number of firms are participating in computer assisted new drug applications (CANDAs), the information technology exchange experiment between the Food and Drug Administration (FDA) and major pharmaceutical makers. The Merck Medical CANDA is an attempt to improve the situation by developing a PC-based, user-friendly system, under MS Windows 3.0, that facilitates quick access, review, assimilation, and presentation of clinical trial data, for the in-house medical and statistical review of the data, as well as for use at the FDA.<>

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[1993] Computer-Based Medical Systems-Proceedings of the Sixth Annual IEEE Symposium

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