Pharmacometric Bridging Approach for U.S. Food and Drug Administration Approval and Identification of Topiramate Dosing Regimen for Pediatric Patients 2-9 Years of Age With Epilepsy.
J Pharm Sci
; 108(4): 1598-1603, 2019 04.
Article
em En
| MEDLINE
| ID: mdl-30468826
ABSTRACT
This study was performed to identify an efficacious dosing regimen for U.S. Food and Drug Administration approval of topiramate for initial monotherapy in pediatric patients aged 2-9 years diagnosed with partial onset seizures and primary generalized tonic-clonic seizures using a pharmacometric bridging approach. The approval of topiramate in monotherapy of epilepsy for adult and pediatric patients (10-15 years) was based on efficacy and safety data from clinical trials. Our analysis showed that exposure-response relationship was similar between adult and pediatric patients (6-15 years) treated with topiramate as monotherapy for epilepsy. Specific dosing in pediatric patients 2-9 years of age was derived and included in the simulations by matching predicted exposures in pediatric patients (2-9 years) to a range of exposures observed in adult and pediatric patients (6-9 years) in a previously conducted clinical trial. The analysis allowed for U.S. Food and Drug Administration approval of topiramate for initial monotherapy in pediatric patients (2-9 years).
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Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Epilepsia
/
Topiramato
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Modelos Biológicos
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Anticonvulsivantes
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article