Sandrine Boulet, Moreno Ursino, Robin Michelet, Linda Bs Aulin, Charlotte Kloft, Emmanuelle Comets, Sarah Zohar
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 dose range...
March 6, 2024: Statistical Methods in Medical Research