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[DOI] [PMC free article] [PubMed] [Google Scholar] 75.Communal C, Singh K, Sawyer DB and Colucci WS

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Modulates GABA system maintaining inhibitory-excitatory balance

Since the concept of adaptive clinical trial design was introduced in the 2004 FDA Strategic Path Initiative, more SAD/MAD combo studies have been conducted, which has been estimated to reduce timelines as much as 12 months compared with separate trials.49 The appeal of the combo design is the advantage of conducting SAD and MAD studies in parallel with the possibility of investigating new doses in adaptive cohorts, although it does demand predefined implementation of restrictive start and stop criteria to ensure safety

Zozulia, A