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Updated: Mar 11, 2026

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
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PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development

Gilbert J Burckart1, Susan Abdel-Rahman2, Caleb Choi2

  • 1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Bldg 51 Rm 3184, 10903 New Hampshire Ave, Silver Spring, Maryland, 20903, USA. gilbert.burckart@fda.hhs.gov.

The AAPS Journal
|March 10, 2026
PubMed
Abstract

Keywords:
bioequivalencebiorelevantoral formulationspediatricsphysiologically-based biopharmaceutics modeling

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