臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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39 巻, 5 号
選択された号の論文の31件中1～31を表示しています
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特集／日本における動脈硬化性疾患の臨床試験　意義，実施体制，デザインとエンドポイントに関する考察，結果の解釈
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  • 後発医薬品会社における個別症例安全性報告の因果関係評価基準
    高月 公博, 古川 裕之, 宮本 謙一
    2008 年 39 巻 5 号 p. 173-179
    発行日: 2008年
    公開日: 2009/02/05
    DOIhttps://doi.org/10.3999/jscpt.39.173
    ジャーナル フリー
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    The purpose of this study was to determine the items necessary for causality assessment in order to improve the usefulness of the individual case safety report (ICSR) from medical institutions as adverse drug reaction (ADR) information. Thus, we evaluated the standard items for causality assessment by surveying the items used in pharmaceutical manufacturers of generic drugs. The number of respondents was 35, which was 89.7% of the member companies of Japan Generic Pharmaceutical Manufacturers Association. The use of algorithms for causality assessment, terms for causal relation, and criteria for assessing whether or not ADR were varied among the companies. These findings were similar to the previous results in a survey of pharmaceutical companies of original drug. The variety of assessment criteria is inconvenient for reporters to judge and also lowers the validity of judgment. Additionally, it will be inappropriate to assess ADR information all together. And these variations may cause wide differences in the frequency measurement of ADR. Therefore, it is crucial to immediately derive consensus on international assessment criteria for causality assessment.
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  • 臨床試験支援者の教育システム構築のための現状把握および教育コンテンツの検討
    小川 智美, 古川 裕之, 内潟 将宏, 畠 真理子, 宮本 謙一
    2008 年 39 巻 5 号 p. 181-186
    発行日: 2008年
    公開日: 2009/02/05
    DOIhttps://doi.org/10.3999/jscpt.39.181
    ジャーナル フリー
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    The systematic education is needed now, because more expectations are placed on clinical research coordinator (CRC) whose duties range from clinical trials for drug development to clinical research. The purpose of this study was to grasp the present conditions of the education opportunity for CRC and to examine the education content in order to build a better education system. The number of survey respondents was 187 (32.9%) among the total of 568 surveys distribution. Half of person was hard to take education, and time and distance were outstanding as the cause. They answered that the fundamentals of “GCP” are very important as a learning item. The need to raise understanding of fundamentals such as “ethical problem”, “compensation”, and “data management” was suggested. As well as substantiality of the training on the national scale, it was thought that teaching materials for self-learning, such as e-learning, we will be necessary for the improvement of knowledge and professional ability of CRC.
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TOPICS
第１４回　臨床薬理学講習会（2007年度）
エビデンスの読み方・使い方
第２８回　日本臨床薬理学会年会記録
シンポジウム１２　病院における臨床薬理学の役割と貢献
第２回　日本臨床薬理学会／日本薬理学会共催シンポジウム記録
「β遮断薬　心不全薬としての薬理から臨床薬理」
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