Modeling and simulations to support dose selection for eslicarbazepine acetate therapy in pediatric patients with partial-onset seizures

Author:

Sunkaraneni Soujanya,Ludwig Elizabeth,Fiedler-Kelly Jill,Hopkins Seth,Galluppi Gerald,Blum David

Funder

Sunovion Pharmaceuticals Inc.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Reference26 articles.

1. Nunes T, Rocha JF, Falcao A, Almeida L, Soares-da-Silva P (2013) Steady-state plasma and cerebrospinal fluid pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine in healthy volunteers. Epilepsia 54:108–116. https://doi.org/10.1111/j.1528-1167.2012.03595.x

2. AAP News (2016) Food and Drug Administration update, 6 April 2016. http://www.aappublications.org/news/2016/04/06/FDAUpdate040616 . Accessed 25 Aug 2017

3. Mehrotra S (2016) Quantitative analysis to support full extrapolation of efficacy in children for partial onset seizures in adjunctive setting: FDA-PEACE initiative, January 2016. http://pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/pedsextrapolation/mehrotra-presentation-notes.pdf . Accessed 5 May 2017

4. Men AY (2015) Assessing quality and quantity of data to establish exposure-response similarity between adults and pediatric patients: PEACE initiative, January 2015. https://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/centers/cersievents/pediatricpbpk/Men%20-%20PEACE%20Initiative.pdf . Accessed 5 May 2017

5. Pellock JM, Carman WJ, Thyagarajan V, Daniels T, Morris DL, D’Cruz O (2012) Efficacy of antiepileptic drugs in adults predicts efficacy in children: a systematic review. Neurology 79:1482–1489. https://doi.org/10.1212/WNL.0b013e31826d5ec0

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