Ontology highlight
ABSTRACT:
SUBMITTER: Combes FP
PROVIDER: S-EPMC7180003 | biostudies-literature | 2020 Apr
REPOSITORIES: biostudies-literature
Combes Francois Pierre FP Einolf Heidi J HJ Coello Neva N Heimbach Tycho T He Handan H Grosch Kai K
CPT: pharmacometrics & systems pharmacology 20200405 4
Everolimus is currently approved in Europe as an adjunctive therapy for patients aged ≥ 2 years with tuberous sclerosis complex (TSC)-associated treatment-refractory partial-onset seizures, based on the EXIST-3 study (NCT01713946) results. As TSC-associated seizures can also affect children aged between 6 months and 2 years, a modeling and simulation (M&S) approach was undertaken to extrapolate exposure (trough plasma concentration (C<sub>min</sub> )) after a dose of 6 mg/m<sup>2</sup> and reduc ...[more]