Gaps for GLP data management in Japan to data integrity guidance
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- OKABAYASHI Yoshito
- Shionogi & Co., Ltd.
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- HAGIWARA Naofumi
- Asahi Kasei Pharma Corporation
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- JOHKI Shigeru
- Astellas Pharma Inc.
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- TAKAYAMA Asami
- LSI Medience Corporation
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- TAKEDA Kinue
- LSI Medience Corporation
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- CHO Fumi
- LSI Medience Corporation
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- MATSUNAGA Hidemitsu
- Otsuka Pharmaceutical Factory, Inc.
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- OHTA Ryo
- Food and Drug Safety Center
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- KONDO Fuminori
- Sumitomo Chemical Co., Ltd.
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- OHNO Rie
- Taisho Pharmaceutical Co., Ltd.
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- KAWASHIMA Yasunaga
- Takeda Pharmaceutical Co., Ltd.
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- ITO Misae
- Chugai Pharmaceutical Co., Ltd.
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- HIRAYAMA Yoko
- NIPPON SHINYAKU CO., LTD
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- NAKAMA Takuya
- FUJIFILM Toyama Chemical Co., Ltd.
Bibliographic Information
- Other Title
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- データインテグリティガイダンスに対する日本のGLPデータ管理のギャップ
Abstract
<p>We analyzed the gap between the GXP data integrity guidance issued by the Medicines & Healthcare products Regulatory Agency (MHRA) and the current state of GLP data management in Japan. As a result, the gaps that had a strong impact were related to governance systems, blank format management, and computerized system management. Among them, the gap for blank format management and computerized system management was thought to require significant costs and tasks to fully address the gap.</p>
Journal
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- Annual Meeting of the Japanese Society of Toxicology
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Annual Meeting of the Japanese Society of Toxicology 47.1 (0), P-248-, 2020
The Japanese Society of Toxicology
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Details 詳細情報について
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- CRID
- 1390285697591660928
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- NII Article ID
- 130007898404
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed