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Novel Targets For Therapeutic Intervention in Inflammatory Bowel Disease. What is the Best Way to Assess the Safety Profile of a Drug?

[ Vol. 25 , Issue. 1 ]

Author(s):

Clara Yzet, Stacy S. Tse, Maia Kayal, Robert Hirten and Jean-Frédéric Colombel*   Pages 57 - 63 ( 7 )

Abstract:


The emergence of biologic therapies has revolutionized the management of inflammatory bowel disease (IBD) by halting disease progression, increasing remission rates and improving long-term clinical outcomes. Despite these well-described benefits, many patients are reluctant to commence therapy due to drug safety concerns. Adverse events can be detected at each stage of drug development and during the post-marketing period. In this article, we review how to best assess the safety parameters of new IBD medications, from the earliest stage of development to population-based registries, with a focus on the special populations often excluded from the evaluation process.

Keywords:

Drug development, safety, adverse effect, side effect, biologics, inflammatory bowel disease, clinical trials.

Affiliation:

Gastroenterology, Amiens University Hospital, Amiens, Division of Gastroenterology, Mount Sinai Hospital, New York, NY, Division of Gastroenterology, Icahn School of Medicine, Mount Sinai, New York, NY, Division of Gastroenterology, Icahn School of Medicine, Mount Sinai, New York, NY, Division of Gastroenterology, Icahn School of Medicine, Mount Sinai, New York, NY



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