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Current Pharmaceutical Design


ISSN (Print): 1381-6128
ISSN (Online): 1873-4286

Review Article

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

Author(s): Clara Yzet, Stacy S. Tse, Maia Kayal, Robert Hirten and Jean-Frédéric Colombel*

Volume 25 , Issue 1 , 2019

Page: [57 - 63] Pages: 7

DOI: 10.2174/1381612825666190308102021

Price: $65


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.

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