Discussions on Identifying Seizures Liability in Nonclinical Studies

1 lug 2024 · 25 min. 26 sec.
Discussions on Identifying Seizures Liability in Nonclinical Studies
Descrizione

Drug-induced seizures are a major concern for central nervous system active pharmaceuticals during development. Currently, there are no guidelines for interrogating and mitigating seizure liability associated with new pharmaceuticals. Because...

mostra di più
Drug-induced seizures are a major concern for central nervous system active pharmaceuticals during development. Currently, there are no guidelines for interrogating and mitigating seizure liability associated with new pharmaceuticals. Because of the risks to patient safety during clinical trials, the understanding of nonclinical characterization that informs the translation of risks to humans is an area of intense interest among drug developers and regulators. A Continuing Education course was held at the 2022 ACT Annual Meeting in Denver, Colorado, where Dr. Delatte presented on identifying seizure liability in nonclinical studies. In this interview with Dr. Delatte, we discuss nonclinical findings that are indicative of seizure liability and appropriate approaches to characterize risks. Many drug classes carry seizure liability which may trigger preliminary studies, such as kindling studies, to understand risks prior to conducting a repeat-dose toxicology study. A description of premonitory signs of seizure in dose-range findings and repeat-dose toxicology studies is also discussed. Finally, this talk briefly discusses when nonclinical EEG studies are warranted and how to leverage the data from general toxicology studies to design an informative EEG study. Learning objectives of this talk are: (1) set up a drug development program for drugs in a class with seizure liability; (2) identify seizure liability in nonclinical studies; and (3) examine the elements from general toxicology studies that inform the pivotal EEG study.
mostra meno
Informazioni
Autore ACT ToxChats
Organizzazione ACT ToxChats
Sito -
Tag

Sembra che non tu non abbia alcun episodio attivo

Sfoglia il catalogo di Spreaker per scoprire nuovi contenuti

Corrente

Copertina del podcast

Sembra che non ci sia nessun episodio nella tua coda

Sfoglia il catalogo di Spreaker per scoprire nuovi contenuti

Successivo

Copertina dell'episodio Copertina dell'episodio

Che silenzio che c’è...

È tempo di scoprire nuovi episodi!

Scopri
La tua Libreria
Cerca