序文　HARPER の翻訳および関連する本企画について-Reference-Cited by-同舟云学术

序文　HARPER の翻訳および関連する本企画について

Published:2023-06-30 Issue:1 Volume:28 Page:13-16
ISSN:1342-0445
Container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
language:en
Short-container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku

Author:

FUKASAWA Toshiki¹,IWAGAMI Masao¹,HARA Azusa¹,NONAKA Takahiro¹,URUSHIHARA Hisashi¹

Affiliation:

1. HARPER Translation Working Group

Publisher

Japanese Society for Pharmacoepidemiology

Subject

General Medicine

Link

https://www.jstage.jst.go.jp/article/jjpe/28/1/28_28.13/_pdf

Reference12 articles.

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2. 2) 岩上将夫，奥山絢子．日々集められている診療情報を用いて薬の安全性や効果を検討する時に報告するべきこと～RECORD-PE とは～．医療の質・安全学会誌 2020；15（1）：17-20．

3. 3) Wang SV, Pottegård A, Crown W, et al. HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects： A Good Practices Report of a Joint ISPE/ISPOR Task Force. Value Health 2022；25（10）：1663-72.

4. 4) Wang SV, Pottegård A, Crown W, et al. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects： A good practices report of a joint ISPE/ISPOR task force. Pharmacoepidemiol Drug Saf 2023； 32（1）： 44-55.

5. 5) European Medicines Agency. Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies. [https://www.ema.europa.eu/en/documents/other/guidance-format-content-protocol-non-interventional-post-authorisation-safety-studies_en.pdf （accessed 2023-5-15）］