新ＧＣＰによる本院の新薬治験への取り組みと現況

DOI 被引用文献1件 参考文献7件

書誌事項

タイトル別名
  • Counterplans and Present States for a Clinical Trial of New Drugs Based on New GCP in our University Dental Hospital.

この論文をさがす

抄録

At present, development work for new drugs is demanded on accompanying pressing needs in the medical world. Clinical trials for new drugs as the latest products may increase gradually in medical facilities based on new GCP, and we must correspond to them with flexibility, though probably influenced by different quantity and quality in clinical trials. In our University Dental Hospital, the office-work division and pharmaceutical services play roles with different duties as to treatment fees and management of drug storage, respectively. This must be surely based between contract workers and corresponding clients for clinical trials. For the execution of practical use, a committee composed of members of the institutional review board (IRB), who must be practically working, including two members chosen from outside, and moreover its office, were established also in our Hospital in 1999. In addition, a cooperation system organized by clinical research coordinators (CRC) was set up to maintain safe and suitable responsibility of clinician's activity, and we also made up a guideline for standard procedures concerning clinical trials of new drugs.<BR>Our aim is to build up a system for clinical trials of new drugs and medical management based on new GCP. Furthermore, we aim continually to improve clinical trials in the future.

収録刊行物

  • 歯科薬物療法

    歯科薬物療法 20 (1), 39-44, 2001

    日本歯科薬物療法学会

被引用文献 (1)*注記

もっと見る

参考文献 (7)*注記

もっと見る

キーワード

詳細情報 詳細情報について

問題の指摘

ページトップへ