ReviewClinical pharmacology and therapeutics2025
Model-Informed Drug Development Applications and Opportunities in mRNA-LNP Therapeutics.
Review in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
7 citing papers in PubMed.
- New approach methodologies (NAMs) for preclinical and translational evaluation of mRNA-lipid nanoparticle (LNP) therapeutics.Journal of controlled release : official journal of the Controlled Release Society · 2026Review
- Physiologically based pharmacokinetic modeling of mRNA therapeutics: A multiscale framework for LNP and antibody trafficking in mice.Molecular therapy. Nucleic acids · 2026Article
- Pharmacokinetic/Pharmacodynamic Translation and Model-Informed Drug Development for Oligonucleotide Therapeutics.Journal of clinical pharmacology · 2026Review
- Whole-Body Pharmacokinetics of Lipid, mRNA and Translated Protein Following Intravenous Administration of Spike Protein Expressing mRNA-LNP in Mice.Pharmaceutical research · 2026Article
- Nanoparticle Drug Delivery Systems: The Future Direction for the Treatment of Tumors.International journal of nanomedicine · 2026Review
- Bench to Bedside Modeling of mRNA Encoding IgG Using a Multiscale Mechanistic Pharmacokinetic-Toxicokinetic (PK-TK) Model: A Case Study With Anti-Claudin 18.2.Clinical and translational science · 2025Article
- PEGylated lipids in lipid nanoparticle delivery dynamics and therapeutic innovation.Beilstein journal of nanotechnology · 2025Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The utilization of lipid nanoparticles (LNP) for encapsulating mRNA has revolutionized the field of therapeutics, enabling the rapid development of COVID-19 vaccines and cancer vaccines. However, the clinical development of mRNA-LNP therapeutics faces numerous challenges due to their complex mechanisms of action and limited clinical experience. To overcome these hurdles, Model-Informed Drug Development (MIDD) emerges as a valuable tool that can be applied to mRNA-LNP therapeutics, facilitating the evaluation of their safety and efficacy through the integration of data from all stages into appropriate modeling and simulation techniques. In this review, we provide an overview of current MIDD applications in mRNA-LNP therapeutics clinical development using in vivo data. A variety of modeling methods are reviewed, including quantitative system pharmacology (QSP), physiologically based pharmacokinetics (PBPK), mechanistic pharmacokinetics/pharmacodynamics (PK/PD), population PK/PD, and model-based meta-analysis (MBMA). Additionally, we compare the differences between mRNA-based therapeutics, small interfering RNA, and adeno-associated virus-based gene therapies in terms of their clinical pharmacology, and discuss the potential for mutual sharing of MIDD knowledge between these therapeutics. Furthermore, we highlight the promising future opportunities for applying MIDD approaches in the development of mRNA-LNP drugs. By emphasizing the importance of applying MIDD knowledge throughout mRNA-LNP therapeutics development, this review aims to encourage stakeholders to recognize the value of MIDD and its potential to enhance the safety and efficacy evaluation of mRNA-LNP therapeutics.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.