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Regulatory Science of Medicinal Products and Medical Devices Lab (Medical and Hygienic Pharmaceutical Sciences)
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A lab that studies drug discovery focused on biological barriers, and regulatory science for pharmaceuticals and medical devices.
AboutAbout the lab
Whoever masters regulation masters innovation.
The Regulatory Science of Medicinal Products and Medical Devices Lab develops innovative drug discovery technologies and conducts research in regulatory science.
Focusing on the molecular basis of biological barriers, the lab works on DDS research, such as drug delivery to the brain and transdermal and oral administration technologies, and on developing disease biomarkers.
Through education in regulatory literacy and regulatory communication, the lab aims to train human resources for health and medical innovation who are also well versed in regulatory science.
The lab strives to let students pursue research themes that interest them, and widely accepts students regardless of university or faculty as long as they have an interest in and motivation for research.
Key terms
- DDS
- Technology that delivers a drug to the needed place in the body in a suitable form. Short for drug delivery system.
- Biological barrier
- Mechanisms that separate the inside and outside of the body and of tissues. Tight junctions, which seal the gaps between epithelial and endothelial cells, are one example.
- Regulatory science
- A field that studies, from a scientific standpoint, how pharmaceuticals and medical devices should be evaluated and regulated.
NewsLab news
A doctoral student received the Early Career Award Best Poster Presentation Recognition at Eurotox2026
A faculty member received the Outstanding Oral Presenter Award at the 16th Annual Meeting of the Japan Society for Regulatory Science
A student received the Student Excellent Presentation Award at the 145th Annual Meeting of the Pharmaceutical Society of Japan
An undergraduate student received the Student Excellent Presentation Award at the 144th Annual Meeting of the Pharmaceutical Society of Japan
ResearchResearch themes
Building on the development and advancement of innovative drug discovery technologies, the lab conducts drug discovery research focused on biological barriers and research in regulatory science. It develops diagnostic and treatment technologies for central nervous system diseases, evaluation technologies for gut microbiota-based drug discovery, functional excipients, and medical digital transformation technologies, together with their application to regulatory science.
*Illustrative imageDrug discovery focused on biological barriers
Biological barriers, which separate the inside and outside of the body and of tissues, include tight junctions that seal the gaps between epithelial and endothelial cells. Focusing on this molecular basis, the lab develops DDS technologies and methods to diagnose and treat diseases.
*Illustrative imageDeveloping diagnostic and treatment technologies for central nervous system diseases
For neurodegenerative and psychiatric diseases, which increase as society ages, the lab develops DDS technologies that lead to therapeutic drugs, and technologies for diagnosing these diseases.
*Illustrative imageDeveloping evaluation technologies for gut microbiota-based drug discovery
Gut microbiota-based drug discovery requires analyzing drug-drug interactions in a different way from conventional approaches. The lab develops methods for evaluating efficacy and safety that are specific to this kind of drug discovery.
*Illustrative imageDeveloping new functional excipients
The lab develops functional excipients such as vaccine adjuvants and absorption enhancers, aiming at technologies that allow all drugs to be administered in patient-friendly forms.
MembersFaculty
The Regulatory Science of Medicinal Products and Medical Devices Lab consists of faculty members, doctoral students (including working professionals), undergraduate students, secretaries, and laboratory assistants.As of 2026
- ProfessorMasuo Kondoh
- Assistant ProfessorYuki Niwa
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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: “Drug delivery ru” Ширинский Владимир Павлович, Борисенко Григорий Геннадиевич, Бородин Павел Андреевич / CC BY-SA 3.0 (cropped)
- Drug discovery focused on biological barriers: “Epithelial Barrier” Rachel Sanchez Thwing / CC BY 4.0 (cropped)
- Developing diagnostic and treatment technologies for central nervous system diseases: “Blood brain barrier Alzheimer's” Dong Wang, Fanglian Chen, Zhaoli Han, Zhenyu Yin, Xintong Ge, Ping Lei / CC BY 4.0 (cropped)
- Developing evaluation technologies for gut microbiota-based drug discovery: “Enterobacter cloacae MacConkey colonies 93” A doubt / CC BY-SA 4.0 (cropped)
- Developing new functional excipients: “Hand tablet press in exposition History of making of drugs in Kuks Hospital in Kuks, Trutnov District” Jiří Sedláček / CC BY-SA 4.0 (cropped)
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（化学薬学領域） ): “Ballon bi-col 250mL” MrXandorf / CC BY-SA 4.0 (cropped) - Related lab (臨床薬理学分野
（医療・衛生薬学領域） ): “Fluoritablets” Kulmalukko / CC BY-SA 3.0 (cropped) - Related lab (神経薬理学分野
（医療・衛生薬学領域） ): “Muscarinic receptor M2 coupled to protein G - 6OIK” Vcilleros / CC BY-SA 4.0 (cropped) - Related lab (医療薬学分野
（医療・衛生薬学領域） ): “Former pharmacy, shelves with medicines” Zalasem1 / CC BY 4.0 (cropped)
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