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Phase IIIb Trial
Definition 1
A type of Phase III trial executed near the time of approval to elicit additional findings. This type of trial may be required as a condition of regulatory authority approval. (NCI Thesaurus)
Definition 2
A subcategory of Phase III trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approval. (NCI Thesaurus/CDISC)
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