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Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines.
Ratitch, Bohdana; Goel, Niti; Mallinckrodt, Craig; Bell, James; Bartlett, Jonathan W; Molenberghs, Geert; Singh, Pritibha; Lipkovich, Ilya; O'Kelly, Michael.
Afiliación
  • Ratitch B; Eli Lilly, Montreal, Quebec, Canada.
  • Goel N; Kezar Life Sciences, South San Francisco, CA, USA.
  • Mallinckrodt C; Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
  • Bell J; Biogen, Cambridge, MA, USA.
  • Bartlett JW; Elderbrook Solutions GmbH, High Wycombe, United Kingdom.
  • Molenberghs G; Department of Mathematical Sciences, University of Bath, Bath, United Kingdom.
  • Singh P; I-BioStat, Universiteit Hasselt and KU Leuven, Hasselt, Belgium.
  • Lipkovich I; Novartis, Basel, Switzerland.
  • O'Kelly M; Eli Lilly, Indianapolis, IN, USA.
Ther Innov Regul Sci ; 54(2): 370-384, 2020 03.
Article en En | MEDLINE | ID: mdl-32072586
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Asma / Trastorno Depresivo Mayor Tipo de estudio: Guideline / Prognostic_studies / Qualitative_research Idioma: En Revista: Ther Innov Regul Sci Año: 2020 Tipo del documento: Article
Texto completo
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Asma / Trastorno Depresivo Mayor Tipo de estudio: Guideline / Prognostic_studies / Qualitative_research Idioma: En Revista: Ther Innov Regul Sci Año: 2020 Tipo del documento: Article