Bayesian framework for multi-source data integration-Application to human extrapolation from preclinical studies
Sandrine Boulet,
Moreno Ursino,
Robin Michelet
et al.
Abstract:In preclinical investigations, for example, in in vitro, in vivo, and in silico studies, the pharmacokinetic, pharmacodynamic, and toxicological characteristics of a drug are evaluated before advancing to first-in-man trial. Usually, each study is analyzed independently and the human dose range does not leverage the knowledge gained from all studies. Taking into account all preclinical data through inferential procedures can be particularly interesting in obtaining a more precise and reliable starting dose and… Show more
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