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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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  19. 6179

    Oxidative Stress Induced Damage and Early Senescence in Preterm Placenta by Yudianto Budi Saroyo, Noroyono Wibowo, Rima Irwinda, Ani Retno Prijanti, Evy Yunihastuti, Saptawati Bardosono, Sofie Rifayani Krisnadi, Putri Indah Permata, Stephanie Wijaya, Victor Prana Andika Santawi

    Published 2021-01-01
    “…Senescent cells have been demonstrated to release High Mobility Group Box 1 (HMGB1) which induces labor through an inflammatory pathway. …”
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  20. 6180

    Effects of Meaningful Action Observation Therapy on Occupational Performance, Upper Limb Function, and Corticospinal Excitability Poststroke: A Double-Blind Randomized Control Tria... by Aryan Shamili, Afsoon Hassani Mehraban, Akram Azad, Gholam Reza Raissi, Mohsen Shati

    Published 2022-01-01
    “…Clinical outcomes were evaluated using the Canadian Occupational Performance Measure (COPM), Fugl-Meyer Assessment (FMA), Action Research Arm Test (ARAT), and Box-Block Test (BBT) on 3 occasions: baseline, post (at 4 weeks), and follow-up (at 8 weeks). …”
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