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Expediting Drug Development in Japan: A PMDA Perspective.

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Title: Expediting Drug Development in Japan: A PMDA Perspective.
Authors: Kohno Y; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Ishiguro A; Department of International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Yasukawa T; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Yasuda N; Department of International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Tanaka D; Department of International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Araki Y; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Takahashi Y; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Uyama Y; Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Fujiwara Y; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2025 Dec; Vol. 118 (6), pp. 1262-1264. Date of Electronic Publication: 2025 Aug 04.
Publication Type: Journal Article; Review
Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE
Database: MEDLINE Ultimate
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Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 40757691
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PubType: Academic Journal
PubTypeId: academicJournal
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  Data: Expediting Drug Development in Japan: A PMDA Perspective.
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  Data: <searchLink fieldCode="AU" term="%22Kohno+Y%22">Kohno Y</searchLink>; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Ishiguro+A%22">Ishiguro A</searchLink>; Department of International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Yasukawa+T%22">Yasukawa T</searchLink>; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Yasuda+N%22">Yasuda N</searchLink>; Department of International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Tanaka+D%22">Tanaka D</searchLink>; Department of International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Araki+Y%22">Araki Y</searchLink>; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Takahashi+Y%22">Takahashi Y</searchLink>; Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Uyama+Y%22">Uyama Y</searchLink>; Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Fujiwara+Y%22">Fujiwara Y</searchLink>; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
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  Data: <searchLink fieldCode="JN" term="%220372741%22">Clinical pharmacology and therapeutics</searchLink> [Clin Pharmacol Ther] 2025 Dec; Vol. 118 (6), pp. 1262-1264. <i>Date of Electronic Publication: </i>2025 Aug 04.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Wiley%22">Wiley </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>0372741 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1532-6535 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200099236%22">00099236 </searchLink><i>NLM ISO Abbreviation: </i>Clin Pharmacol Ther <i>Subsets: </i>MEDLINE
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      – Type: doi
        Value: 10.1002/cpt.70022
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      – Code: eng
        Text: English
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            – D: 01
              M: 12
              Text: 2025 Dec
              Type: published
              Y: 2025
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