Quantitative Systems Toxicology Modeling with DILIsym to Support Phase 3 Dose Selection for Fezolinetant.

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Title: Quantitative Systems Toxicology Modeling with DILIsym to Support Phase 3 Dose Selection for Fezolinetant.
Authors: Nielsen JC; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA., Woodhead JL; Simulations Plus, Inc., Research Triangle Park, North Carolina, USA., Howell BA; Simulations Plus, Inc., Research Triangle Park, North Carolina, USA., Shoda LKM; Simulations Plus, Inc., Research Triangle Park, North Carolina, USA., Parasrampuria DA; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA., Huang J; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA., Iwai M; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA., Ottery FD, Wang X; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA., English M; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA., Miyazaki K; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA., Watkins PB; University of North Carolina, Chapel Hill, North Carolina, USA.
Source: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2026 Apr; Vol. 119 (4), pp. 1016-1024. Date of Electronic Publication: 2026 Jan 16.
Publication Type: Journal Article
Journal Info: Publisher: Wiley Country of Publication: United States NLM ID: 0372741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-6535 (Electronic) Linking ISSN: 00099236 NLM ISO Abbreviation: Clin Pharmacol Ther Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Nielsen+JC%22">Nielsen JC</searchLink>; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Woodhead+JL%22">Woodhead JL</searchLink>; Simulations Plus, Inc., Research Triangle Park, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Howell+BA%22">Howell BA</searchLink>; Simulations Plus, Inc., Research Triangle Park, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Shoda+LKM%22">Shoda LKM</searchLink>; Simulations Plus, Inc., Research Triangle Park, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Parasrampuria+DA%22">Parasrampuria DA</searchLink>; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Huang+J%22">Huang J</searchLink>; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Iwai+M%22">Iwai M</searchLink>; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Ottery+FD%22">Ottery FD</searchLink><br /><searchLink fieldCode="AU" term="%22Wang+X%22">Wang X</searchLink>; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22English+M%22">English M</searchLink>; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Miyazaki+K%22">Miyazaki K</searchLink>; Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Watkins+PB%22">Watkins PB</searchLink>; University of North Carolina, Chapel Hill, North Carolina, USA.
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        Value: 10.1002/cpt.70194
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              Text: 2026 Apr
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