The Japanese Journal of Antibiotics
Online ISSN : 2186-5477
Print ISSN : 0368-2781
ISSN-L : 0368-2781
小児科領域抗菌薬臨床試験における判定基準
その目的と作成経過
藤井 良知小林 裕西村 忠史砂川 慶介岩田 敏目黒 英典豊永 義清秋田 博伸久野 邦義岩井 直一本廣 孝新納 憲司
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ジャーナル フリー

1993 年 46 巻 8 号 p. 736-747

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This paper describes the purpose and process for establishing “Criteria for Clinical Evaluation of Antibiotics in the Pediatric Field”, which was reported in the Japanese Journal of Antibiotics Vol.46, May, 1993. The Criteria Committee was organized in November 1991. Four meetings were held to establish the draft criteria. The criteria were applied to the evaluation of oral cephem S-1108 and parenteral cephem SCE-2787. When the criteria were compared with the conventional criteria, the results indicated that no difference was obtained in the efficacy rate as a whole, the sum of “Good” and “Excellent” cases, but there was a difference in the cases judged to be “Excellent”. Partial alteration was made to the draft criteria and the Committee produced the final version of the criteria. However, the criteria are far from complete, so it will be subjected to further revision it accordance with future advance in chemotherapy.

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© 公益財団法人 日本感染症医薬品協会
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