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Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses.

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Title: Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses.
Authors: Morris NM; Certara Predictive Technologies (CPT), Certara UK Limited, Simcyp Division, level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK. Natalie.Morris@certara.com., Jamei M; Certara Predictive Technologies (CPT), Certara UK Limited, Simcyp Division, level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK., Alam K; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA., Tsakalozou E; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA., Donnelly M; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA., Feng K; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA., Bois FY; Certara Predictive Technologies (CPT), Certara UK Limited, Simcyp Division, level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.
Source: The AAPS journal [AAPS J] 2026 Apr 03; Vol. 28 (3). Date of Electronic Publication: 2026 Apr 03.
Publication Type: Journal Article
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses.
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  Data: <searchLink fieldCode="AU" term="%22Morris+NM%22">Morris NM</searchLink>; Certara Predictive Technologies (CPT), Certara UK Limited, Simcyp Division, level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK. Natalie.Morris@certara.com.<br /><searchLink fieldCode="AU" term="%22Jamei+M%22">Jamei M</searchLink>; Certara Predictive Technologies (CPT), Certara UK Limited, Simcyp Division, level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.<br /><searchLink fieldCode="AU" term="%22Alam+K%22">Alam K</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Tsakalozou+E%22">Tsakalozou E</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Donnelly+M%22">Donnelly M</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Feng+K%22">Feng K</searchLink>; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Bois+FY%22">Bois FY</searchLink>; Certara Predictive Technologies (CPT), Certara UK Limited, Simcyp Division, level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2026 Apr 03; Vol. 28 (3). <i>Date of Electronic Publication: </i>2026 Apr 03.
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        Value: 10.1208/s12248-026-01215-0
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      – TitleFull: Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses.
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              Text: 2026 Apr 03
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