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。1)
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.2)
1)
药物临床试验质量管理规范(GCP). 国家药品监督管理局. 2020
2)
ICH GCP (E6(R2)). ICH. 2016