Assessing Information Gaps Associated with Initial Pediatric Study Plans for New Oncology Drug and Biological Products.

Guinn, Daphne; Gafford, Marilyn; Burckart, Gilbert J; Reaman, Gregory; Charlab, Rosane

Guinn, Daphne; Gafford, Marilyn; Burckart, Gilbert J; Reaman, Gregory; Charlab, Rosane.

Afiliación

Guinn D; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Gafford M; Harding University College of Pharmacy, Searcy, Arkansas, USA.
Burckart GJ; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Reaman G; Oncology Center of Excellence, Office of the Commissioner, and Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Charlab R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Clin Pharmacol Ther ; 114(3): 618-622, 2023 09.

Article en En | MEDLINE | ID: mdl-37422730

Asunto(s)

Productos Biológicos; Neoplasias; Adulto; Humanos; Niño; Estados Unidos; Productos Biológicos/uso terapéutico; Neoplasias/tratamiento farmacológico; Oncología Médica; United States Food and Drug Administration

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Neoplasias Tipo de estudio: Risk_factors_studies Límite: Adult / Child / Humans País/Región como asunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

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