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  • 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. NOTE: CDISC includes test articles in its definition of investigational products. Compare to authorised investigational medicinal product from EU-CTR (EU) No 536/2014. [ICH]
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