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

Saved in:
Bibliographic Details
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
Description
ISSN:1550-7416
DOI:10.1208/s12248-026-01215-0