Appendix 2

Masao Iwagami; Kotonari Aoki; Manabu Akazawa; Chieko Ishiguro; Shinobu Imai; Nobuhiro Ooba; Makiko Kusama; Daisuke Koide; Atsushi Goto; Norihiro Kobayashi; Izumi Sato; Sayuri Nakane; Makoto Miyazaki; Kiyoshi Kubota

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Appendix 2

VernacularTitle:付録 2 ：データベース研究に関連するガイドライン・ガイダンスにおけるバリデーション研究に関する記載の要約
Author: Masao IWAGAMI ¹ ; Kotonari AOKI ² ; Manabu AKAZAWA ³ ; Chieko ISHIGURO ⁴ ; Shinobu IMAI ⁵ ; Nobuhiro OOBA ⁶ ; Makiko KUSAMA ⁷ ; Daisuke KOIDE ⁸ ; Atsushi GOTO ⁹ ; Norihiro KOBAYASHI ¹⁰ ; Izumi SATO ¹¹ ; Sayuri NAKANE ¹² ; Makoto MIYAZAKI ² ; Kiyoshi KUBOTA ¹³
Author Information

1. London School of Hygiene and Tropical Medicine
2. Real World Data Science Dept., Drug Safety Div., Chugai Pharmaceutical Co.Ltd.
3. Department of Public Health and Epidemiology, Meiji Pharmaceutical University
4. Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency
5. Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters
6. Nihon University School of Pharmacy
7. Graduate School of Pharmaceutical Sciences, The University of Tokyo
8. Current address：Japan Agency for Medical Research and Development（AMED)
9. Graduate School of Medicine, The University of Tokyo
10. Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center
11. Digital Intelligence Department, Corporate Strategy Division, Shionogi & Co., Ltd.
12. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University
13. Risk Assessment & Pharmacoepidemiology, MSD K.K.
From:Japanese Journal of Pharmacoepidemiology 2018;23(2):125-130
CountryJapan
Language:Japanese