福岡大学病院における臨床研究用試験薬の調製

概要

論文の詳細を見る
In Fukuoka University Hospital, the Clinical Research Assist Center and Department of Pharmacy provide support for clinical studies with a view to ensuring the ethical soundness, reliability, and scientific precision of investigator-initiated clinical research as well as commercially-based clinical trials. For an investigator-initiated comparative clinical study conducted according to a randomized, placebo-controlled design using the double dummy method, pharmacists from the Dept. of Pharmacy prepared the placebo and packaged it and commercially available medicines in blister package sheets. The Institutional Review Board of Fukuoka University Hospital approved this study based on the assumption that the preparation of the investigational agents fulfilled the quality control guidelines of Good Manufacturing Practice. In conclusion, we were able to contribute to improving the quality of translational research through the preparation of investigational agents.
日本医療薬学会の論文
2008-01-10