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  1. No Access

    Article

    Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan

    The Medical Information Database Network (MID-NET®) in Japan is a vast repository providing an essential pharmacovigilance tool. Gastrointestinal perforation (GIP) is a critical adverse drug event, yet no well-es...

    Masatoshi Tanigawa, Mei Kohama, Kaori Hirata… in Therapeutic Innovation & Regulatory Science (2024)

  2. Article

    Open Access

    Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET® in Japan

    Intestinal perforation and obstruction are known to be one of the adverse events caused by antipsychotics; however, warning information on package inserts varies among antipsychotics. To investigate the risks ...

    Tomoaki Hasegawa, Sono Sawada… in Therapeutic Innovation & Regulatory Science (2024)

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  3. Article

    Correction: Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

    Mei Kohama, Takahiro Nonaka, Yoshiaki Uyama… in Therapeutic Innovation & Regulatory Science (2023)

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  4. No Access

    Article

    Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

    Japanese pharmaceutical authorities have conducted regulatory renovations of pharmacovigilance planning (PVP) since implementing new procedures for develo** post-marketing study plans in 2018 in order to pro...

    Mei Kohama, Takahiro Nonaka, Yoshiaki Uyama… in Therapeutic Innovation & Regulatory Science (2023)