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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.
Jean, Daphney; Naik, Kunal; Milligan, Lauren; Hall, Stephen; Mei Huang, Shiew; Isoherranen, Nina; Kuemmel, Colleen; Seo, Paul; Tegenge, Million A; Wang, Yaning; Yang, Yuching; Zhang, Xinyuan; Zhao, Liang; Zhao, Ping; Benjamin, Jessica; Bergman, Kimberly; Grillo, Joseph; Madabushi, Rajanikanth; Wu, Fang; Zhu, Hao; Zineh, Issam.
Afiliación
  • Jean D; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Naik K; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Milligan L; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Hall S; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Mei Huang S; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Isoherranen N; School of Pharmacy, University of Washington, Seattle, Washington, USA.
  • Kuemmel C; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Seo P; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Tegenge MA; Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Yang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhang X; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhao L; Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhao P; Bill & Melinda Gates Foundation, Seattle, Washington, USA.
  • Benjamin J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Bergman K; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Grillo J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wu F; Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhu H; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zineh I; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
CPT Pharmacometrics Syst Pharmacol ; 10(11): 1271-1275, 2021 11.
Article en En | MEDLINE | ID: mdl-34536337

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Farmacología Clínica Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: CPT Pharmacometrics Syst Pharmacol Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Farmacología Clínica Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: CPT Pharmacometrics Syst Pharmacol Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos