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Background: Use of health applications (apps) to support healthy lifestyles has intensified. Different app features may support effectiveness, including gamification defined as the use of game elements in a non-game situation. Whether health apps with gamification can impact behaviour change and cardiometabolic risk factors remains unknown.

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Background: Patients with end-stage kidney disease (ESKD) have high rates of gastrointestinal bleeding due to several risk factors including platelet dysfunction, comorbid illness, and use of antiplatelet medications. Proton pump inhibitors (PPIs) reduce gastrointestinal bleeding and are recommended for high-risk patients such as those prescribed dual antiplatelet therapy (DAPT). Whether inappropriate duration of DAPT therapy and/or lack of appropriate PPI use contribute to the known elevated risk of gastrointestinal bleeding in hemodialysis patients is not known.

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Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan.

J Pharmacokinet Pharmacodyn

January 2025

Clinical Pharmacology Development Area, MSD K.K., Tokyo, Japan.

Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness and application of MIDD in Japan, the Data Science Expert Committee of the Drug Evaluation Committee in the Japan Pharmaceutical Manufacturers Association established a task force, which surveyed MIDD applications for approved products in Japan. This study aimed to reveal the trends and challenges in the use of MIDD by analyzing the survey results.

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Purpose: National Comprehensive Cancer Network Guidelines recommend initiating postoperative radiation therapy (PORT) within 6 weeks of surgery for patients with head and neck squamous cell carcinoma (HNSCC), but delays affect 50% of patients, disproportionately burden minoritized groups, and contribute to worse oncologic outcomes. This trial evaluates the efficacy of Navigation for Disparities and Untimely Radiation thErapy (NDURE), an enhanced navigation-based intervention, relative to usual care (UC) patient navigation for starting timely PORT.

Methods: Adults with locally advanced HNSCC planning to undergo surgery and PORT were randomly assigned 1:1 to standard multidisciplinary head and neck oncology care and either NDURE, a multilevel navigation-based intervention to enhance key processes of care and overcome barriers to timely PORT, or UC, which consisted of standard patient navigation.

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Importance: Despite their importance to patients, health, and industry, the magnitude of investments in drug research and development (R&D) remain nebulous. New policies require more granular and transparent R&D cost estimates to better balance incentives for innovation and returns to developers.

Objective: To estimate per-drug R&D costs using a novel, reproduceable approach and to describe firm-level R&D costs per discrete unit of R&D activity (1 patient-month).

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