显示页面修订记录反向链接回到顶部 本页面只读。您可以查看源文件,但不能更改它。如果您觉得这是系统错误,请联系管理员。 CKG 可视编辑器 ====== 试验用药品 IP / IMP ======= \\ **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)) **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)) \\ 概念/试验用药品.txt 最后更改: 2年前由 老T