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Model-Informed Drug Development: Steps Toward Harmonized Guidance.
Marshall, Scott; Ahamadi, Malidi; Chien, Jenny; Iwata, Daisuke; Farkas, Pavel; Filipe, Augusto; Frey, Nicolas; Greene, Erin; Kawai, Norisuke; Li, Jian; Lippert, Jörg; Musuamba Tshinanu, Flora; Manolis, Efthymios; Peterson, Mark C; Sarem, Sarem; Shebley, Mohamad; Tegenge, Million; Tsai, Chia-Hsun; Tu, Chien-Lung; Otsubo, Yasuto; Wei, Jiawei; Zhang, Lucia; Zhu, Hao; Karlsson, Kristin E.
Afiliación
  • Marshall S; Clinical Pharmacology Modelling and Simulation, GSK, Stevenage, UK.
  • Ahamadi M; Clinical Pharmacology Modeling and Simulation, AMGEN, Thousand Oaks, California, USA.
  • Chien J; Global PK/PD & Pharmacometrics, Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Iwata D; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Farkas P; Global Clinical Operations, Teva, Zagreb, Croatia.
  • Filipe A; Nonclinical and Clinical R&D, Tecnimede SA, Lisbon, Portugal.
  • Frey N; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.
  • Greene E; International Regulatory Sciences & Policy, Pfizer, New York, New York, USA.
  • Kawai N; Clinical Research, Pfizer R&D Japan, Tokyo, Japan.
  • Li J; National Medical Products Administration, Beijing, China.
  • Lippert J; Pharmacometrics, Bayer, Berlin, Germany.
  • Musuamba Tshinanu F; Federal Agency for Medicines and Health Products, Brussels, Belgium and University of Namur, Namur, Belgium.
  • Manolis E; European Medicines Agency, Amsterdam, The Netherlands.
  • Peterson MC; Clinical & Quantitative Pharmacology, Vertex Pharmaceuticals, Boston, Massachusetts, USA.
  • Sarem S; Health Canada/Pharmaceutical Drugs Directorate, Ottawa, Ontario, Canada.
  • Shebley M; Clinical Pharmacology, AbbVie, North Chicago, Illinois, USA.
  • Tegenge M; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, USA.
  • Tsai CH; Center for Drug Evaluation (CDE), Taipei, Taiwan.
  • Tu CL; Center for Drug Evaluation, Taipei, Taiwan.
  • Otsubo Y; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Wei J; Novartis Institutes for Biomedical Research Co., Shanghai, China.
  • Zhang L; Health Canada, Biologic and Radiopharmaceutical Drugs Directorate, Ottawa, Ontario, Canada.
  • Zhu H; US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland, USA.
  • Karlsson KE; Swedish Medical Products Agency, Uppsala, Sweden.
Clin Pharmacol Ther ; 114(5): 954-959, 2023 Nov.
Article en En | MEDLINE | ID: mdl-37534711
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Texto completo: 1 Base de datos: MEDLINE Tipo de estudio: Guideline Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Tipo de estudio: Guideline Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido