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      Clinical Development in Drug Repurposing

      Published
      proceedings-article
      1 , 1 , 1
      ScienceOpen
      RExPO22
      2-3 September, 2022
      Clinical Trials, Good Clinical Practice (GCP), Guidelines, Drug Repurposing, Innovation
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            Abstract

            Preparing, executing and analyzing a clinical trial is a highly complex process that requires in depth knowledge of GCP, knowledge and experience in clinical science and – most of all – an entrepreneurial spirit and creativity in order to optimize the development of a new drug treatment. Especially in the case of trials for repurposed medicines, creativity and innovation can be a key denominator in the way the program is designed, what makes it such an exciting journey. For generic drugs and new chemical or biologic entities strict rules and guidelines are applicable and need to be followed and determine the amount of non-clinical and clinical evidence that needs to be delivered. For repurposed drugs, the body of evidence is different in every case, and it is up to the project team to come up with the best and most efficient development program. The author will take you on this journey, using real life examples, failures and successes with the aim to inspire the audience to make the most out of the journey that we are about to embark on in the REPO4EU program

            Content

            Author and article information

            Conference
            ScienceOpen
            17 August 2022
            Affiliations
            [1 ] 3D-PharmXchange, Tilburg, The Netherlands
            Article
            10.14293/S2199-rexpo22003.v1
            c4825335-e6b2-4924-8828-db38095fff10
            The Authors

            Published under Creative Commons Attribution 4.0 International ( CC BY 4.0). Users are allowed to share (copy and redistribute the material in any medium or format) and adapt (remix, transform, and build upon the material for any purpose, even commercially), as long as the authors and the publisher are explicitly identified and properly acknowledged as the original source.

            RExPO22
            Maastricht, Netherlands
            2-3 September, 2022
            History

            Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
            Guidelines,Innovation,Drug Repurposing,Good Clinical Practice (GCP),Clinical Trials

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