Výsledky vyhledávání - "Katja Kallivroussis"

A Framework Proposal to Follow-Up on Preclinical Convulsive Signals of a New Molecular Entity in First-in-Human Studies Using Electroencephalographic Monitoring

Autor: Richard Peck, Elisabeth Husar, Robert Dannecker, Markus Abt, Christoph Wandel, Theo Dinklo, Lucette Doessegger, Katja Kallivroussis, Andreas Rothfuss

Publikováno v: Clinical Pharmacology and Therapeutics

Traditionally, in dose-escalating first-in-human (FiH) studies, a dose cap with a 10-fold safety margin to the no observed effect level in animals is implemented if convulsive events are observed in animals. However, the convulsive risk seen in anima

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cb8ceab56de28c94971150d54042f8c8
https://pubmed.ncbi.nlm.nih.gov/30993670

Zobrazit plný text záznamu

Vyhledávací nástroje:

Upřesnit hledání