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

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 animals does not generally translate to humans. Several...

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Detalles Bibliográficos
Autores principales: Abt, Markus, Dinklo, Theo, Rothfuss, Andreas, Husar, Elisabeth, Dannecker, Robert, Kallivroussis, Katja, Peck, Richard, Doessegger, Lucette, Wandel, Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851537/
https://www.ncbi.nlm.nih.gov/pubmed/30993670
http://dx.doi.org/10.1002/cpt.1455

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851537/
https://www.ncbi.nlm.nih.gov/pubmed/30993670
http://dx.doi.org/10.1002/cpt.1455

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