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[制药行业的角色与职责]

[The roles and responsibilities of the pharmaceutical industry].

作者信息

Dejgaard Anders, Thomsen Mads Krogsgaard

机构信息

Novo Nordisk A/S, Krogshøjvej bygning 9E, DK-2880 Bagsvaerd.

出版信息

Ugeskr Laeger. 2003 Apr 14;165(16):1676-9.

Abstract

A major part of clinical research in Denmark involves clinical testing of pharmaceuticals sponsored by the pharmaceutical industry. All these trials are carried out according to Good Clinical Practice (GCP) and necessitate a close working relationship between responsible investigators and the pharmaceutical industry. It is of mutual interest that these trials should have a high scientific standard and that the integrity of patients always has the highest priority. Many guidelines, laws and conventions regulate this area to ensure the fulfilment of these goals. In the present article, we describe the roles and responsibilities that pharmaceutical companies have to comply with.

摘要

丹麦临床研究的一个主要部分涉及由制药行业赞助的药品临床试验。所有这些试验均按照《药物临床试验质量管理规范》(GCP)进行,需要负责的研究者与制药行业之间保持密切的工作关系。这些试验应具有较高的科学标准,且患者的权益始终是重中之重,这符合双方的利益。许多指南、法律和公约对该领域进行规范,以确保这些目标得以实现。在本文中,我们描述了制药公司必须遵守的角色和职责。

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