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Challenges and opportunities for IBD drug development: from early stage to regulatory approval

Authors

  • Silvio Danese Department of Gastroenterology, IBD Center, Humanitas Clinical and Research Center- IRCCS, Milan, Italy Department of Biomedical Sciences, Humanitas University, Milan, Italy PubMed articlesGoogle scholar articles
  • Elmer Schabel Licensing Division 2, Federal Institute for Drugs and Medical Devices, Bonn, Germany PubMed articlesGoogle scholar articles
  • Mark Andrew Ainsworth Department of Medical Evaluation and Biostatistics, Danish Medicines Agency, Copenhagen, Denmark Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark PubMed articlesGoogle scholar articles
  • Laurent Peyrin-Biroulet Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France PubMed articlesGoogle scholar articles
  1. Correspondence to Dr Silvio Danese, Istituto Clinico Humanitas, Milan 20089, Italy; sdanese{at}hotmail.com
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Citation

Danese S, Schabel E, Ainsworth MA, et al
Challenges and opportunities for IBD drug development: from early stage to regulatory approval
Gut 2020;69:1157-1161.

Publication history

  • Received December 22, 2019
  • Revised January 31, 2020
  • Accepted February 1, 2020
  • First published March 16, 2020.
Online issue publication 
July 13, 2020

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© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.