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PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of pembrolizumab for locally advanced uterine cervical cancer, and durvalumab and olaparib for advanced or recurrent endometrial cancer in Japan.
Int J Clin Oncol
December 2024
Japan Society of Clinical Oncology, Editorial Committee, Tokyo, Japan.
Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.
Mol Pharm
December 2024
Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
This report summarizes the proceedings for Day 3 of the workshop titled "". This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the regulatory agencies perspectives. The presentations, which included several case studies, covered the applications of PBBM in generic drug product development, applications of virtual bioequivalence trials to support formulation bridging and the utility of absorption modeling in clinical pharmacology assessments.
View Article and Find Full Text PDFA retrospective study of seasonal variation in sodium-glucose co-transporter 2 inhibitor-related adverse events using the Japanese adverse drug event report database.
Sci Rep
December 2024
Laboratory of Drug Informatics, Gifu Pharmaceutical University, 1-25-4, Daigaku-nishi, Gifu, 501-1196, Japan.
Article Synopsis
- * The study identified seasonal trends in adverse events like dehydration, cerebral infarction, urinary tract infections, and ketoacidosis linked to six SGLT2 inhibitors prescribed in Japan.
- * Findings showed dehydration-related issues were most common in summer and winter, with a peak for cerebral infarction in February, suggesting healthcare professionals should be vigilant about dehydration risks throughout the year.
Has risk management plan system influenced the speed of package insert revisions in Japan?
Front Med (Lausanne)
October 2024
Department of Regulatory Science, Graduate School of Pharmaceutical Science, Meiji Pharmaceutical University, Tokyo, Japan.
Introduction: The system of Risk Management Plan in Japan (J-RMP) is a relatively new system, implemented in 2013; thus, its effect on safety measures is still unclear. One of the purposes of J-RMP is to enhance the postmarketing safety measures to be ensured by publishing J-RMP and sharing information on risk management among healthcare professionals. We hypothesized that this might enable information about postmarketing adverse events to be accumulated rapidly, potentially accelerating the identification of adverse reactions (ARs).
View Article and Find Full Text PDFTrend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.
AAPS J
November 2024
Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-Ku, Tokyo, 100-0013, Japan.
Generics and biosimilars play an important role in sustaining the universal healthcare insurance systems in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) reviews the quality, efficacy, and safety of generics and biosimilars for marketing authorization in Japan. Trend analyses of generics and biosimilars in terms of regulatory science have rarely been published.
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