DSUR ICH
由 ICHHT GUIDELINE 著作 · 被引用 2 次 — A DSUR should be concise and provide information to assure regulators that sponsors are adequately monitoring and evaluating the evolving safety ... ,2020年4月9日 — The development safety update report (DSUR) proposed in this guidance is intended to be a common standard for periodic reporting on drugs ...
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 DSUR ICH 相關參考資料
Development Safety Development Safety Update Report ( ...
di t DSUR. ▫ Appendices to DSUR. ▫ Glossary. 17. Page 18. Obj ti f th DSUR. Objective of the DSUR. The DSUR presents an annual review & evaluation of safety ... https://database.ich.org Development Safety Update Report E2F
由 ICHHT GUIDELINE 著作 · 被引用 2 次 — A DSUR should be concise and provide information to assure regulators that sponsors are adequately monitoring and evaluating the evolving safety ... https://database.ich.org E2F Development Safety Update Report
2020年4月9日 — The development safety update report (DSUR) proposed in this guidance is intended to be a common standard for periodic reporting on drugs ... https://www.fda.gov ICH E2F
https://www.fda.gov.tw ICH E2F Development safety update report - Scientific guideline
It defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission. Keywords: ... https://www.ema.europa.eu ICH E2F指引產業教育訓練課程
2023年4月6日 — 本指引規定DSUR之建議內容與格式，並概述了在編寫和繳交過程中應考慮的要點。目前，部分ICH國家及區域規定須向主管機關繳交定期報告，以提供上述資料。 https://www.cde.org.tw ICH guideline E2F on development safety update report - Step 5
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development ... https://www.ema.europa.eu 國際醫藥法規協和會(ICH)指引採認清單
... (ICH)指引採認清單」，說明ICH 指引重點、適用範圍及我國目前相. 對應參考 ... 建立(DSUR)；此類似於就. 上市後藥品之藥物安全. 監視期間藥品定期安全. 性報告(PSUR). https://www.fda.gov.tw 當代醫藥法規月刊第145期
2. DSUR的主要目的是透過(1)審視試驗委託者在通報期間所得到的資料是否與試驗藥品先前已知的安全性資料相符；(2)說明可能對於臨床試驗受試者保護造成影響之新的安全問題；( ... https://www.cde.org.tw |