investigational product
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- 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.
- Use
- investigational medicinal product
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