Principles and methods of pharmacoepidemiology: A framework for the pharmacoepidemiologic decision-making process.:A Framework for the Pharmacoepidemiologic Decision-Making Process

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At any stage from the drug research and development phase to the post-marketing clinical use of drugs, using epidemiologic methods would be useful. The authors evaluated and elaborated the concept of pharmacoepidemiology. For this purpose, the epidemiologic research methods, both observational and interventional, were examined for application to pharmaceuticals.<BR>Providing a framework for epidemiologic research on pharmaceuticals, we proposed a new scheme of a "pharmacoepidemiologic decision-making process." It revealed that three kinds of decision-making are important in the process: the decision-making at the research and development level; the decision-making at the population level; and the decision-making at the individual level.<BR>Two examples relating to the pharmacological research and development process were illustrated: population pharmacokinetics and post-marketing studies. The authors showed the function and effectiveness of the concept of the pharmacoepidemiologic decision-making process in the examples, and discussed the relationship between the individual and the population in pharmacoepidemiology.
一般社団法人日本臨床薬理学会の論文