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INTRODUCTION

Medical Pharmacy

Laboratory of Regulatory Science

Regulatory science research on methods for predicting and assessing the safety and efficacy of pharmaceuticals

Regulatory science is an academic discipline that aims to align science and technology to the most desirable form for society by implementing accurate assessments, predictions, and judgments based on scientific grounds when applying science and technology to human society. For example, drugs have both side effects and expected efficacy, but the damage of side effects can be minimized if they can be addressed in advance by way of risk assessment and predictive analysis. This laboratory is a “dry lab” where we employ integration analysis and data mining in an effort to assess and predict the efficacy and safety of drugs. By conducting analyses that integrate data from various databases including Japanese and foreign side effects databases like JADER and FAERS, the Secondary Use of National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), screening reports, and drug risk management plans, we conduct research that contributes to assessing and predicting the efficacy and safety of drugs, more efficient development of pharmaceuticals, and effective post-marketing safety measures. https://www.ritsumei.ac.jp/gsph/