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Evolving Concepts in Phases I and II Drug Development for Crohn's Disease.
Jairath, Vipul; Levesque, Barrett G; Vande Casteele, Niels; Khanna, Reena; Mosli, Mahmoud; Hindryckx, Pieter; Travis, Simon; Duijvestein, Marjolijn; Rimola, Jordi; Panes, Julian; D'Haens, Geert; Sandborn, William J; Feagan, Brian G.
Afiliación
  • Jairath V; Department of Medicine, University of Western Ontario, London, ON, Canada.
  • Levesque BG; Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, ON, Canada.
  • Vande Casteele N; Nuffield Department of Experimental Medicine, University of Oxford, Oxford, UK.
  • Khanna R; Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, ON, Canada.
  • Mosli M; Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
  • Hindryckx P; Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, ON, Canada.
  • Travis S; Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
  • Duijvestein M; KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
  • Rimola J; Department of Medicine, University of Western Ontario, London, ON, Canada.
  • Panes J; Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, ON, Canada.
  • D'Haens G; Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Sandborn WJ; Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, ON, Canada.
  • Feagan BG; University Hospital of Ghent, Ghent, Belgium.
J Crohns Colitis ; 11(2): 246-255, 2017 02.
Article en En | MEDLINE | ID: mdl-27487793
The highest attrition rates during drug development programmes occur at the proof of concept stage. Given the large number of molecules under development for Crohn's disease, a need exists to improve the efficiency of early drug development by fast-tracking promising agents and terminating ineffective ones. Multiple opportunities are available to achieve these goals, including the use of more responsive outcome measures, and the incorporation of sophisticated pharmacokinetic modelling and/or highly specific pharmacodynamic markers into exposure-based dosing regimens and novel trial designs. In this article we review these strategies and propose an integrated paradigm of early drug development in Crohn's disease.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fármacos Gastrointestinales / Enfermedad de Crohn / Aprobación de Drogas Límite: Humans Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fármacos Gastrointestinales / Enfermedad de Crohn / Aprobación de Drogas Límite: Humans Idioma: En Revista: J Crohns Colitis Asunto de la revista: GASTROENTEROLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido