Investigational product – any pharmaceutical form of an active ingredient or placebo being studied or used as a reference in a clinical trial. This term incorporates investigational drugs, biologics, medical devices, or procedures that are under examination for their safety and efficacy in clinical research.
Definitions
ICH E6(R2)
- 1.33 Investigational Product:
- 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 [1].
See also
Another relevant pages
Links to this page
- Clinical research (← links)
- Regulatory inspection (← links)
- IMP (redirect page) (← links)
- Monitoring report (← links)
- Nonclinical study (← links)
- Protocol (← links)
- Quality assurance (← links)
- Regulation (EU) No 536/2014 (← links)
- Sponsor-investigator (← links)
- Sub-investigator (← links)
- Clinical research regulations in the European Union (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
External links