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--- 概念:试验用药品 [2021/01/17 15:56]
127.0.0.1 外部编辑
+++ 概念:试验用药品 [2022/02/25 04:10] (当前版本)
老T
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-==== 试验用药品 / Investigational Product / IP ====
+====== 试验用药品 IP / IMP =======
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+\\
+　　**试验用药品**：指用于临床试验的试验药物、对照药品。(([[法规:药物临床试验质量管理规范|药物临床试验质量管理规范（GCP）]]. [[概念:国家药品监督管理局]]. 2020))
-<font inherit/inherit;;inherit;;#FFFF00>（[[系统:待完成?do=backlink|待完成]]）</font>
+　　**Investigational Product (IP)** or **Investigational Medicinal Product (IMP)**：A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH]]. 2016))
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