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Extrapolation of Adult Efficacy Data to Pediatric Systemic Lupus Erythematosus: Evaluating Similarities in Exposure-Response.
Balevic, Stephen J; Niu, Jing; Chen, Jianmeng; Green, Dionna; McMahon, Ann; Hornik, Christoph P; Schanberg, Laura E; Glaser, Rachel; Gonzalez, Daniel; Burckart, Gilbert J.
Afiliación
  • Balevic SJ; Duke Clinical Research Institute, Durham, North Carolina, USA.
  • Niu J; Department of Pediatrics, Duke University, Durham, North Carolina, USA.
  • Chen J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Green D; Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • McMahon A; Office of Pediatric Therapeutics, Office of the Commissioner, United States Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Hornik CP; Office of Pediatric Therapeutics, Office of the Commissioner, United States Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Schanberg LE; Duke Clinical Research Institute, Durham, North Carolina, USA.
  • Glaser R; Duke Clinical Research Institute, Durham, North Carolina, USA.
  • Gonzalez D; Department of Pediatrics, Duke University, Durham, North Carolina, USA.
  • Burckart GJ; Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drugs, CDER, FDA, Silver Spring, Maryland, USA.
J Clin Pharmacol ; 63(1): 105-118, 2023 01.
Article en En | MEDLINE | ID: mdl-35968821

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Azatioprina / Lupus Eritematoso Sistémico Límite: Adult / Child / Humans Idioma: En Revista: J Clin Pharmacol Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Azatioprina / Lupus Eritematoso Sistémico Límite: Adult / Child / Humans Idioma: En Revista: J Clin Pharmacol Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido