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Center for Practical Pharmacy Education and Research, Pharmaceutical Affairs Education and Research Unit Lab
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A lab that studies drug discovery focused on biological barriers, together with regulatory science.
AboutAbout the lab
Whoever masters regulation masters innovation.
The lab in the field of Regulatory Science for Pharmaceuticals and Medical Devices (which also serves as the Pharmaceutical Affairs Education and Research Unit) works on developing innovative drug discovery technologies and on regulatory science research.
Its drug discovery research focuses on the molecular basis of biological barriers, and includes drug delivery to the brain, noninvasive administration technologies such as transdermal and oral delivery, and the development of disease biomarkers.
Through education in regulatory literacy and regulatory communication, the lab aims to train professionals for health and medical innovation who are also well versed in regulatory science.
The lab strives to let students pursue the research themes they are interested in, and accepts students from any university or faculty as long as they have an interest in and motivation for research.
Key terms
- DDS
- Technology for delivering a drug to its target site in the body, or in a way that places less burden on the patient. Short for drug delivery system
- Tight junction
- A mechanism that seals the gaps between epithelial and endothelial cells. It acts as a biological barrier separating the inside and outside of the body and of tissues
- Regulatory science
- A field that approaches the regulations and standards involved in developing and evaluating pharmaceuticals and medical devices from a scientific perspective
NewsLab news
A doctoral student received an Early Career Award (Best Poster Presentation Recognition) at Eurotox2026
A faculty member received an Outstanding Oral Presenter Award at the 16th Annual Meeting of the Society for Regulatory Science
A student received a Student Excellent Presentation Award at the 145th Annual Meeting of the Pharmaceutical Society of Japan
An undergraduate student received a Student Excellent Presentation Award at the 144th Annual Meeting of the Pharmaceutical Society of Japan
ResearchResearch themes
Building on drug discovery research focused on the molecular basis of biological barriers, the lab develops drug delivery system (DDS) technologies and methods for diagnosing and treating diseases. Many of its research themes are set with application to regulatory science as their stated goal.
*Illustrative imageDrug Discovery Focused on Biological Barriers
The mechanisms that seal the gaps between epithelial and endothelial cells (tight junctions) act as biological barriers separating the inside and outside of the body and of tissues. Focusing on their molecular basis, the lab develops DDS technologies and methods for diagnosing and treating diseases.
*Illustrative imageDiagnostic and Therapeutic Technologies for Central Nervous System Disorders
Neurodegenerative and psychiatric disorders are increasing as society ages. The lab develops DDS technologies that lead to therapeutics for central nervous system disorders, as well as diagnostic technologies for these diseases.
Evaluation Technologies for Gut Microbiota-Based Drug Discovery
Gut microbiota-based drug discovery requires analysis of drug-drug interactions in a way that differs from conventional approaches. The lab is developing methods for evaluating efficacy and safety that are specific to this type of drug discovery.
*Illustrative imageDevelopment of Novel Functional Excipients
The lab develops functional excipients such as vaccine adjuvants and absorption enhancers. It aims to develop technologies that allow all pharmaceuticals to be administered in patient-friendly forms.
MembersFaculty
The members of the field of Regulatory Science for Pharmaceuticals and Medical Devices consist of faculty members, a secretary, laboratory assistants, doctoral students (including doctoral students who are working professionals), and undergraduate students.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: “Working at pharmacy with client” Akeeb Feroz / CC BY-SA 4.0 (cropped)
- Drug Discovery Focused on Biological Barriers: “Tight junction 03” Kuebi = Armin Kübelbeck / CC BY 3.0 (cropped)
- Diagnostic and Therapeutic Technologies for Central Nervous System Disorders: “Nose-to-brain drug pathway” GirlBossBME23 / CC BY-SA 4.0 (cropped)
- Development of Novel Functional Excipients: “Micobutin capsules and powder” Inc ru / CC BY-SA 3.0 (cropped)
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