Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti‐seizure medication: Levetiracetam case study

Testing the nonclinical Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm with an established anti‐seizure medication: Levetiracetam case study

Abstract Levetiracetam (LEV), a well‐established anti‐seizure medication (ASM), was launched before the original ICH S7B nonclinical guidance assessing QT prolongation potential and the introduction of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) paradigm. No information was available on it...

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Dettagli Bibliografici
Autori principali: Annie Delaunois, François‐Xavier Mathy, Miranda Cornet, Vitalina Gryshkova, Chloé Korlowski, François Bonfitto, Juliane Koch, Anne‐Françoise Schlit, Simon Hebeisen, Elisa Passini, Blanca Rodriguez, Jean‐Pierre Valentin
Natura: Articolo
Lingua:English
Pubblicazione: Wiley 2023-02-01
Serie:Pharmacology Research & Perspectives
Soggetti:
cardiac safety
CiPA
ICH S7B
levetiracetam
nonclinical
QT prolongation
Accesso online:https://doi.org/10.1002/prp2.1059

Accesso online

https://doi.org/10.1002/prp2.1059

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