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A case study of virtual control group verification using historical control data at a single facility.

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Title: A case study of virtual control group verification using historical control data at a single facility.
Authors: Amano Y; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Takeda Pharmaceutical Co., Ltd., Hara H; Takeda Pharmaceutical Co., Ltd., Takakura I; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Kissei Pharmaceutical Co., Ltd., Tanaharu T; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Bristol-Myers Squibb K.K., Motoyama K; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Johnson & Johnson Innovative Medicine., Nishikawa S; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Tanabe Pharma Corporation., Kurooka T; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; EA Pharma Co., Ltd., Sakai K; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; ASKA Pharmaceutical Co., Ltd., Sato G; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Eisai Co., Ltd., Hashimoto K; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Takeda Pharmaceutical Co., Ltd., Suzuki M; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Kyowa Kirin Co., Ltd.
Source: The Journal of toxicological sciences [J Toxicol Sci] 2026; Vol. 51 (6), pp. 339-348.
Publication Type: Journal Article
Journal Info: Publisher: Doku Sayō Kenkyūkai Country of Publication: Japan NLM ID: 7805798 Publication Model: Print Cited Medium: Internet ISSN: 1880-3989 (Electronic) Linking ISSN: 03881350 NLM ISO Abbreviation: J Toxicol Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: A case study of virtual control group verification using historical control data at a single facility.
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  Data: <searchLink fieldCode="AU" term="%22Amano+Y%22">Amano Y</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Takeda Pharmaceutical Co., Ltd.<br /><searchLink fieldCode="AU" term="%22Hara+H%22">Hara H</searchLink>; Takeda Pharmaceutical Co., Ltd.<br /><searchLink fieldCode="AU" term="%22Takakura+I%22">Takakura I</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Kissei Pharmaceutical Co., Ltd.<br /><searchLink fieldCode="AU" term="%22Tanaharu+T%22">Tanaharu T</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Bristol-Myers Squibb K.K.<br /><searchLink fieldCode="AU" term="%22Motoyama+K%22">Motoyama K</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Johnson & Johnson Innovative Medicine.<br /><searchLink fieldCode="AU" term="%22Nishikawa+S%22">Nishikawa S</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Tanabe Pharma Corporation.<br /><searchLink fieldCode="AU" term="%22Kurooka+T%22">Kurooka T</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; EA Pharma Co., Ltd.<br /><searchLink fieldCode="AU" term="%22Sakai+K%22">Sakai K</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; ASKA Pharmaceutical Co., Ltd.<br /><searchLink fieldCode="AU" term="%22Sato+G%22">Sato G</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Eisai Co., Ltd.<br /><searchLink fieldCode="AU" term="%22Hashimoto+K%22">Hashimoto K</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Takeda Pharmaceutical Co., Ltd.<br /><searchLink fieldCode="AU" term="%22Suzuki+M%22">Suzuki M</searchLink>; Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA).; Kyowa Kirin Co., Ltd.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Doku+Sayō+Kenkyūkai%22">Doku Sayō Kenkyūkai </searchLink><i>Country of Publication: </i>Japan <i>NLM ID: </i>7805798 <i>Publication Model: </i>Print <i>Cited Medium: </i>Internet <i>ISSN: </i>1880-3989 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2203881350%22">03881350 </searchLink><i>NLM ISO Abbreviation: </i>J Toxicol Sci <i>Subsets: </i>MEDLINE
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        Value: 10.2131/jts.51.339
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      – Code: eng
        Text: English
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        StartPage: 339
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            – D: 01
              M: 01
              Text: 2026
              Type: published
              Y: 2026
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