Model‐Informed Drug Development Applications and Opportunities in mRNA‐LNP Therapeutics DOI Creative Commons
Jiawei Zhou, Rohit Rao,

Mark Shapiro

et al.

Clinical Pharmacology & Therapeutics, Journal Year: 2025, Volume and Issue: unknown

Published: March 14, 2025

The utilization of lipid nanoparticles (LNP) for encapsulating mRNA has revolutionized the field therapeutics, enabling rapid development COVID‐19 vaccines and cancer vaccines. However, clinical mRNA‐LNP therapeutics faces numerous challenges due to their complex mechanisms action limited experience. To overcome these hurdles, Model‐Informed Drug Development (MIDD) emerges as a valuable tool that can be applied facilitating evaluation safety efficacy through integration data from all stages into appropriate modeling simulation techniques. In this review, we provide an overview current MIDD applications in using vivo data. A variety methods are reviewed, including quantitative system pharmacology (QSP), physiologically based pharmacokinetics (PBPK), mechanistic pharmacokinetics/pharmacodynamics (PK/PD), population PK/PD, model‐based meta‐analysis (MBMA). Additionally, compare differences between mRNA‐based small interfering RNA, adeno‐associated virus‐based gene therapies terms pharmacology, discuss potential mutual sharing knowledge therapeutics. Furthermore, highlight promising future opportunities applying approaches drugs. By emphasizing importance throughout development, review aims encourage stakeholders recognize value its enhance

Language: Английский

Model‐Informed Drug Development Applications and Opportunities in mRNA‐LNP Therapeutics DOI Creative Commons
Jiawei Zhou, Rohit Rao,

Mark Shapiro

et al.

Clinical Pharmacology & Therapeutics, Journal Year: 2025, Volume and Issue: unknown

Published: March 14, 2025

The utilization of lipid nanoparticles (LNP) for encapsulating mRNA has revolutionized the field therapeutics, enabling rapid development COVID‐19 vaccines and cancer vaccines. However, clinical mRNA‐LNP therapeutics faces numerous challenges due to their complex mechanisms action limited experience. To overcome these hurdles, Model‐Informed Drug Development (MIDD) emerges as a valuable tool that can be applied facilitating evaluation safety efficacy through integration data from all stages into appropriate modeling simulation techniques. In this review, we provide an overview current MIDD applications in using vivo data. A variety methods are reviewed, including quantitative system pharmacology (QSP), physiologically based pharmacokinetics (PBPK), mechanistic pharmacokinetics/pharmacodynamics (PK/PD), population PK/PD, model‐based meta‐analysis (MBMA). Additionally, compare differences between mRNA‐based small interfering RNA, adeno‐associated virus‐based gene therapies terms pharmacology, discuss potential mutual sharing knowledge therapeutics. Furthermore, highlight promising future opportunities applying approaches drugs. By emphasizing importance throughout development, review aims encourage stakeholders recognize value its enhance

Language: Английский

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