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Pharmacoepidemiology involves development of new models to predict safety in the development stages of pharmaceutical products, development of various guidelines and policy related to clinical trials, pharmacovigilance, establishment and implementation of risk management in postmarketing studies, and cost-effectiveness research in medical and social welfare sectors. Evaluations of safety, efficacy, and costs of pharmaceutical products must be developed in a different way. More recently, “big data” in medicine have become the driving force behind epidemiological studies that attempt to solve questions in the clinical setting. Furthermore, it is important to pursue cost-effectiveness considering the government’s financial condition. Epidemiologic and economic research utilizing epidemiological data linked to cost data will provide scientific evidence for appropriate distribution of health resources.

Pharmacoepidemiology in Japan: medical databases and research achievements