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Drug Safety|April 20, 2010
Development safety update reports and proposals for effective and efficient risk communicationHisashi Urushihara, Koji Kawakami
Therapeutic Innovation & Regulatory Science|September 22, 2018
Academic Clinical Trials and Drug Regulations in Japan: Impacts of Introducing the Investigational New Drug SystemHisashi Urushihara, Koji Kawakami
Therapeutic Innovation & Regulatory Science|May 18, 2023
Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/RegionsIsa Inada, Fumiyuki Kiuchi, Hisashi Urushihara
Biosecurity and Bioterrorism : Biodefense Strategy, Practice, and Science|December 6, 2012
Emergency authorization of medical products: regulatory challenges from the 2009 H1N1 influenza pandemic in JapanHisashi Urushihara, Sayako Matsui, Koji Kawakami
Plos One|October 3, 2013
Biased safety reporting in blinded randomized clinical trials: meta-analysis of angiotensin receptor blocker trialsNobuyoshi Takabayashi, Hisashi Urushihara, Koji Kawakami
BMC Infectious Diseases|July 7, 2019
Influenza vaccination effectiveness for people aged under 65 years in Japan, 2013/2014 season: application of a doubly robust method to a large-scale, real-world datasetNatsumi Shibata, Shinya Kimura, Takahiro Hoshino, et al.
The Patient|July 30, 2020
Real World Survey of Patient Engagement Status in Clinical Research: The First Input from JapanNanae Tanemura, Tsuyoshi Sasaki, Junko Sato, et al.
Cancer Reports (Hoboken, N.J.)|January 17, 2021
Searching for potential surrogate endpoints of overall survival in clinical trials for patients with prostate cancerHideki Maeda, Kentaro Takeda, Hisashi Urushihara, et al.
Drugs - Real World Outcomes|August 8, 2024
Prescribing Cascades of Loop Diuretics and Anti-vertigo Drugs Following Treatment with Gabapentinoids and Benzodiazepines: Prescription Sequence Symmetry Analysis of a Large-Scale Claims Database Including Japanese Older AdultsRina Omata, Akane Asami, Azusa Hara, et al.
Trials|March 12, 2021
Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European regionNanae Tanemura, Tsuyoshi Sasaki, Junko Sato, et al.
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