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Model-Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases.
Li, Ruo-Jing; Ma, Lian; Li, Fang; Li, Liang; Bi, Youwei; Yuan, Ye; Li, Yangbing; Xu, Yuan; Zhang, Xinyuan; Liu, Jiang; Bhattaram, Venkatesh Atul; Wang, Jie; Schuck, Robert; Pacanowski, Michael; Zhu, Hao.
Afiliación
  • Li RJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ma L; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li F; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li L; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bi Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yuan Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Li Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Xu Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhang X; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Liu J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bhattaram VA; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wang J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Schuck R; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pacanowski M; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhu H; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
J Clin Pharmacol ; 62 Suppl 2: S27-S37, 2022 12.
Article en En | MEDLINE | ID: mdl-36461744
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Enfermedades Raras / Desarrollo de Medicamentos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Child / Humans Idioma: En Revista: J Clin Pharmacol Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Enfermedades Raras / Desarrollo de Medicamentos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Child / Humans Idioma: En Revista: J Clin Pharmacol Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos