Showing 1 - 7 results of 7 for search '"drug safety"', query time: 0.04s Refine Results
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    Digital twin-enhanced three-organ microphysiological system for studying drug pharmacokinetics in pregnant women by Katja Graf, José Martin Murrieta-Coxca, Tobias Vogt, Sophie Besser, Daria Geilen, Tim Kaden, Tim Kaden, Anne-Katrin Bothe, Diana Maria Morales-Prieto, Behnam Amiri, Behnam Amiri, Stephan Schaller, Ligaya Kaufmann, Martin Raasch, Ramy M. Ammar, Ramy M. Ammar, Christian Maass, Christian Maass

    Published 2025-02-01
    “…Long-term exposure simulations confirmed the value of this integrated system for predicting the non-toxic metabolization of prednisone.ConclusionThis approach may provide a potential non-animal alternative that could contribute to our understanding of drug behavior during pregnancy and may support early-stage drug safety assessment for vulnerable populations.…”
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    Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017 by Bao Liu, Xingyue Zhu

    Published 2022-07-01
    “…Objective To explore the associations between the risks of postmarketing safety events of new drugs and the four expedited programmes of priority review, accelerated approval, fast track and breakthrough therapy established by the US Food and Drug Administration (FDA); and to investigate whether multiple uses of expedited programmes, and the combinations of expedited programmes with orphan designation, were relevant to different safety profiles.Design Cohort study.Setting USA.Participants All new drugs approved by the FDA between 1 January 2007 and 31 December 2017, followed up until 10 April 2021.Outcome measures Safety events included safety-related withdrawal, new boxed warning, drug safety communication, postapproval risk evaluation mitigation strategy and safety-related labelling changes. …”
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    Pregnant Women, a Potential Reservoir for Onchocerca volvulus? A Cross Sectional Study in Maridi County, South Sudan by Chiara Trevisan, Amber Hadermann, Stephen Raimon Jada, Raphael A. Abong, Yak Yak Bol, Joseph N. Siewe Fodjo, Katja Polman, Robert Colebunders

    Published 2025-02-01
    “…Pregnant women may be a parasite reservoir as they are not included in routine ivermectin (IVM) treatments due to unassessed drug safety. In our study we determined the proportion of pregnant women infected with Onchocerca volvulus and assessed the knowledge and practices on IVM use during pregnancy. …”
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    High risk for life-threatening adverse events of fluoroquinolones in young adults: a large German population-based cohort study by Julia Wicherski, Jonas Peltner, Cornelia Becker, Katrin Schüssel, Gabriela Brückner, Andreas Schlotmann, Helmut Schröder, Winfried V. Kern, Britta Haenisch

    Published 2025-02-01
    “…Conclusions This study contributes real-world evidence to endpoint-specific differences of risks in patient subgroups which need to be considered to improve fluoroquinolone drug safety.…”
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