Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data.

Sai, Kimie; Nakatani, Eiji; Iwama, Yasuhiro; Hiraoka, Shuichi; Tohkin, Masahiro; Uyama, Yoshiaki; Saito, Yoshiro

Sai, Kimie; Nakatani, Eiji; Iwama, Yasuhiro; Hiraoka, Shuichi; Tohkin, Masahiro; Uyama, Yoshiaki; Saito, Yoshiro.

Afiliação

Sai K; Division of Medicinal Safety Science, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan. sai@nihs.go.jp.
Nakatani E; Division of Statistical Analysis of Research Support Center, Shizuoka General Hospital, Shizuoka, Japan.
Iwama Y; Regulatory Affairs & Clinical Data Science Department, Meiji Seika Pharma Co., Ltd., Tokyo, Japan.
Hiraoka S; Medical Science Section, Meiji Seika Pharma Co., Ltd., Tokyo, Japan.
Tohkin M; Department of Regulatory Science, Graduate School of Pharmaceutical Science, Nagoya City University, Nagoya, Japan.
Uyama Y; Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency, Tokyo, Japan.
Saito Y; Division of Medicinal Safety Science, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan.

Ther Innov Regul Sci ; 55(3): 523-538, 2021 05.

Article em En | MEDLINE | ID: mdl-33393013

Assuntos

Preparações Farmacêuticas; Esquizofrenia; Disuria; Humanos; Japão; República da Coreia; Estudos Retrospectivos; Esquizofrenia/tratamento farmacológico; Taiwan

Palavras-chave

East Asia; Ethnic difference; ICH E17; Multi-regional clinical trial

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esquizofrenia / Preparações Farmacêuticas Tipo de estudo: Guideline / Observational_studies / Prognostic_studies Limite: Humans País/Região como assunto: Asia Idioma: En Ano de publicação: 2021 Tipo de documento: Article

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