Impact of pharmacometrics in advancing mRNA therapeutics and vaccines

The article discusses the role of pharmacometrics in the development of mRNA therapeutics, emphasizing its significance in informing dose decisions and guiding clinical study designs through mathematical modeling and simulations. It highlights how pharmacometric modeling aids in predicting doses for first-in-human clinical studies based on preclinical data, with case studies illustrating the predictive power of these models. Additionally, the application of pharmacometric modeling in vaccine development is discussed, notably with immunostimulatory/immunodynamic models, showcasing how these models help in successfully predicting clinical responses, thereby guiding dose decisions during clinical development. As the field of mRNA medicines continues to evolve and expand, pharmacometric methodologies are poised to play an increasingly influential role in their clinical development, leveraging data-driven, model-informed strategies.

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