Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam

Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam.

Afiliação

Green DJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Liu XI; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Hua T; University of Michigan College of Pharmacy, Ann Arbor, Michigan, USA.
Burnham JM; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Schuck R; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Pacanowski M; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Yao L; Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver, Spring, Maryland, USA.
McCune SK; Office of Pediatric Therapeutics, Commissioner's Office, US Food and Drug Administration, Silver Spring, Maryland, USA.
Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Zineh I; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Clin Pharmacol Ther ; 104(5): 983-988, 2018 11.

Article em En | MEDLINE | ID: mdl-29218740

Assuntos

Ensaios Clínicos como Assunto/métodos; Aprovação de Drogas/métodos; Desenvolvimento de Medicamentos/métodos; Seleção de Pacientes; Sujeitos da Pesquisa; Fatores Etários; Humanos; Fatores de Tempo; Resultado do Tratamento; Estados Unidos; United States Food and Drug Administration

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Aprovação de Drogas / Seleção de Pacientes / Sujeitos da Pesquisa / Desenvolvimento de Medicamentos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2018 Tipo de documento: Article

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