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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.
Marathe, Anshu; Liu, Chao; Kapcala, Leonard P; Hershkowitz, Norman; Men, Angela; Uppoor, Ramana; Mehta, Mehul; Wang, Yaning.
Afiliación
  • Marathe A; Division of Clinical Pharmacology II, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland 20903.
  • Liu C; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland 20903.
  • Kapcala LP; Division of Neurology Products, Office of New Drugs, CDER, FDA, Silver Spring, Maryland 20903.
  • Hershkowitz N; Division of Neurology Products, Office of New Drugs, CDER, FDA, Silver Spring, Maryland 20903.
  • Men A; Division of Clinical Pharmacology I, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland 20903.
  • Uppoor R; Division of Clinical Pharmacology I, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland 20903.
  • Mehta M; Division of Clinical Pharmacology I, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland 20903.
  • Wang Y; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland 20903. Electronic address: yaning.wang@fda.hhs.gov.
J Pharm Sci ; 108(4): 1598-1603, 2019 04.
Article en En | MEDLINE | ID: mdl-30468826
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Epilepsia / Topiramato / Modelos Biológicos / Anticonvulsivantes Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: J Pharm Sci Año: 2019 Tipo del documento: Article
Texto completo
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Epilepsia / Topiramato / Modelos Biológicos / Anticonvulsivantes Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Límite: Adolescent / Child / Child, preschool / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: J Pharm Sci Año: 2019 Tipo del documento: Article