ICH Revision of Analytical Validation Guideline (Q2(R2)) and Analytical Development Guideline (Q14) ─ Summary and Accounts on the Drafts for Public Comments ─
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- INOUE Keisuke
- Quality Control, Hikari Site Quality, Japan Quality, Global Quality, Takeda Pharmaceutical Company Limited
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- SAMUKAWA Takafumi
- Shionogi Healthcare Co., Ltd.
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- SHIBATA Hiroko
- National Institute of Health Science
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- TAKATSU Mari
- Pharmaceuticals and Medical Devices Agency
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- HIYAMA Yukio
- National Institute of Health Science
Bibliographic Information
- Other Title
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- ICH分析法バリデーションガイドラインの改定（Q2（R2））及び分析法開発ガイドライン（Q14） ─意見公募案の概要と解説─
Journal
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- Pharmaceutical and Medical Device Regulatory Science
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Pharmaceutical and Medical Device Regulatory Science 54 (1), 2-13, 2023
Pharmaceutical and Medical Device Regulatory Science Society of Japan
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Details 詳細情報について
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- CRID
- 1390576844714689408
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- ISSN
- 24366226
- 18846076
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- Text Lang
- ja
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- Data Source
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- JaLC