Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development.

McMahon, Ann W; Watt, Kevin; Wang, Jian; Green, Dionna; Tiwari, Ram; Burckart, Gilbert J

McMahon, Ann W; Watt, Kevin; Wang, Jian; Green, Dionna; Tiwari, Ram; Burckart, Gilbert J.

Afiliación

McMahon AW; Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD, USA.
Watt K; Duke University Medical Center, Durham, NC, USA.
Wang J; Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, Silver Spring, MD, USA.
Green D; Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, Silver Spring, MD, USA.
Tiwari R; Office of Biostatistics, Office of Translational Sciences, Food and Drug Administration, Silver Spring, MD, USA.
Burckart GJ; Office of Clinical Pharmacology, Office of Translational Sciences, Food and Drug Administration, Silver Spring, MD, USA.

Ther Innov Regul Sci ; 20162016.

Article en En | MEDLINE | ID: mdl-27774353

Palabras clave

Kawasaki disease; age groups; modeling; pharmacokinetics pharmacodynamics

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Texto completo: 1 Banco de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Ther Innov Regul Sci Año: 2016 Tipo del documento: Article País de afiliación: Estados Unidos

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