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This manuscript proposes a clinical and quantitative pharmacology framework to facilitate the development of mRNA therapies from preclinical research to clinical development. We discuss the unique pharmacological and ADME properties of mRNA and its lipid nanoparticle (LNP) delivery system, along with key bioanalytical and regulatory considerations. Specific clinical pharmacology strategies and quantitative approaches are illustrated through real\u2010world examples in oncology, rare metabolic diseases, and vaccines. Finally, we propose a forward\u2010looking clinical and quantitative pharmacology framework that integrates translational modeling, population modeling, physiological\u2010based pharmacokinetic (PBPK), quantitative systems pharmacology (QSP), and Artificial Intelligence (AI)\/Machine Learning (ML)\u2010assisted predictive modeling. 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