計量生物学
Online ISSN : 2185-6494
Print ISSN : 0918-4430
ISSN-L : 0918-4430
話題3:Points to Consider on Multiplicity Issues in Clinical Trials
臨床評価における統計学上の論点:医薬品の承認申請および審査における多重性の取り扱いについて
柴田 大朗
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ジャーナル フリー

2006 年 27 巻 Special_Issue 号 p. S78-S87

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In the development and regulatory review of pharmaceuticals, multiplicity is one of the important issues, and an adequate treatment of multiplicity is required by regulatory guidelines. Though the importance of statistically valid adjustment of multiplicity in drug development is nowadays well understood by practitioners, the more is required in the view of government agencies responsible for drug evaluation. To use the drug effectively and safely in clinical practice, not only the validity of the method itself, but also the validity of the formulation of clinical questions and the adequacy of the interpretation of results are required. In this article, two examples of new drug application review results, one by the US FDA and the other by the Japanese regulatory agency, are reviewed and discussed.
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© 2006 日本計量生物学会
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