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Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability.

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Title: Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability.
Authors: Morris NM; Certara Predictive Technologies (CPT), Certara UK, Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK. Natalie.Morris@certara.com., Djehizian A; Certara Predictive Technologies (CPT), Certara UK, Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK., Mittapelly N; Certara Predictive Technologies (CPT), Certara UK, Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK., Telaprolu KC; Certara Predictive Technologies (CPT), Certara UK, Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK., Holland BW; Certara Predictive Technologies (CPT), Certara UK, Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK., McNally K; Certara Predictive Technologies (CPT), Certara UK, Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK., Polak S; Certara Predictive Technologies (CPT), Certara UK, Certara UK Limited, Simcyp Division, Level 2-Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.; Jagiellonian University Medical College, Faculty of Pharmacy, Krakow, Poland., Jamei M; Certara Predictive Technologies (CPT), Certara UK, 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, MD, United States of America., Tsakalozou E; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, MD, United States of America., Donnelly M; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, MD, United States of America., Feng K; Division of Quantitative Methods and Modeling, Office of Research and Standards/OGD/CDER/FDA, Silver Spring, MD, United States of America., Bois FY; Certara Predictive Technologies (CPT), Certara UK, 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
Description
ISSN:1550-7416
DOI:10.1208/s12248-026-01213-2