Pediatric dosing for locally acting drugs in submissions to the U.S. Food and Drug Administration between 2002 and 2020.

Abulwerdi, Gelareh A; Ramamoorthy, Anuradha; Bashaw, Edward; Burckart, Gilbert J; Madabushi, Rajanikanth; Fletcher, Elimika Pfuma

Abulwerdi, Gelareh A; Ramamoorthy, Anuradha; Bashaw, Edward; Burckart, Gilbert J; Madabushi, Rajanikanth; Fletcher, Elimika Pfuma.

Afiliación

Abulwerdi GA; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Ramamoorthy A; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Bashaw E; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Madabushi R; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Fletcher EP; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Clin Transl Sci ; 16(10): 2046-2057, 2023 10.

Article en En | MEDLINE | ID: mdl-37551830

Asunto(s)

Aprobación de Drogas; Desarrollo de Medicamentos; Adulto; Estados Unidos; Niño; Humanos; Preparaciones Farmacéuticas; United States Food and Drug Administration; Relación Dosis-Respuesta a Droga

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / Desarrollo de Medicamentos Límite: Adult / Child / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Transl Sci Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

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