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Drug Evaluation Science Lab
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The lab scientifically analyzes the value of pharmaceuticals and the systems for their development and regulation.
AboutAbout the lab
Evaluating pharmaceuticals in their societal context
The lab studies the evaluation of the efficacy and safety of pharmaceuticals, as well as the systems for their development and regulation.
Its research and education go beyond the scientific evaluation of drugs to cover their medical and social value, as well as drug administration and legal systems.
Its aims are to train the specialists needed to bring pharmaceuticals into practical use, to raise the quality of clinical trials and new drug approval reviews, and to get the drugs patients want to the clinical setting sooner.
In addition to graduate students, the lab offers lectures and courses that professionals from pharmaceutical companies and government agencies can also take.
Key terms
- Drug lag
- The delay before a drug already in use overseas becomes available in Japan
- Approval review
- The procedure by which the government decides, based on efficacy and safety data, whether a new drug may be put on the market
- Package insert
- The official instructions attached to a drug, describing how to use it, its side effects, and more
ResearchResearch themes
The lab conducts research that combines the natural science and social science aspects of drug evaluation science. It quantifies and analyzes the value of pharmaceuticals and various aspects of research, development, and regulation.
*Illustrative imagePerformance Evaluation of Pharmaceutical Regulatory Administration
The lab objectively compiles Japan's track record in new drug development and analyzes issues such as the use of foreign clinical data, pre-submission consultations, and cooperation with overseas regulatory authorities.
*Illustrative imageDrug Lag and Its Causes
Within the drug lag, the lab focuses on delays in the development period leading up to the approval application and delays during development, and quantitatively analyzes their causes.
*Illustrative imageRegional Differences in Drug Evaluation
The lab examines differences in approved doses among Japan, the US, and Europe, as well as ethnic differences in adverse events observed in clinical trials, and investigates their causes. It also compares the adverse drug reaction reporting systems of Japan, China, and the US.
*Illustrative imageGlobalization of Clinical Trials and Use of Evidence
Focusing on the number of post-marketing safety measures (revisions of package inserts) and their relationship to drug lag and application dossiers, the lab examines how these relate to clinical trial data from Japan and abroad and to post-marketing evidence.
MembersFaculty
The lab's members consist of faculty, students in the doctoral program (including working professionals), the master's program, and the undergraduate program, researchers, and administrative staff.
- Professor (Concurrent)Urano YasuteruPublications ↗
- Associate ProfessorShunsuke Ono
- LecturerYoshiaki Kariya
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Report an errorAbout the images
The top and research theme images are illustrative and were not taken at the lab. They are cropped from Wikimedia Commons images. Cropped CC BY-SA images are provided under the same CC BY-SA license as the original (version shown on each line).
- Top image: “Gelules-et-comprimes” Root66 / CC BY-SA 3.0 (cropped)
- Performance Evaluation of Pharmaceutical Regulatory Administration: “Shin-Kasumigaseki Building” Hagitomo125 / CC BY-SA 4.0 (cropped)
- Drug Lag and Its Causes: “Pills - Flickr - michaeln3” Michael Nutt from New York, US / CC BY-SA 2.0 (cropped)
- Regional Differences in Drug Evaluation: “Polish Doxepin Pilva (doxepine) tablets, 10 and 25 mg” Żółwiciel / CC BY-SA 3.0 (cropped)
- Globalization of Clinical Trials and Use of Evidence: “Drug Package Insert (FDA )” The U.S. Food and Drug Administration / Public domain (cropped)
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ゅらさん / CC BY-SA 4.0 (cropped) - Related lab (医療政策・
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