著者

吉村 功 椿 広計 佐藤 喬俊 厳 浩 山本 精一郎 森田 智視 船渡川 伊久子 柴田 大朗 伊藤 陽一 松山 裕

出版者

日本計量生物学会

雑誌

計量生物学 (ISSN:09184430)

巻号頁・発行日

vol.42, no.1, pp.1-13, 2021 (Released:2022-04-22)

著者

柴田 大朗

出版者

日本計量生物学会

雑誌

計量生物学 (ISSN:09184430)

巻号頁・発行日

vol.27, no.Special_Issue, pp.S78-S87, 2006-09-30 (Released:2012-01-23)

参考文献数

15

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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.

著者

花岡 英紀 北田 光一 小室 一成 金澤 薫 柴田 大朗 齋藤 康

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.42, no.3, pp.161-162, 2011 (Released:2011-10-03)