著者

永井 尚美

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.41, no.5, pp.217-222, 2010 (Released:2010-11-25)

参考文献数

19

被引用文献数

2 1

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Pharmacokinetics-Pharmacodynamics (PK-PD) is useful to understand the quantitative relationship between drug exposure and pharmacological outcome. In recent years, results of the pharmacokinetic analysis of Japanese patients have been frequently included in the new drug application dossier. Also, not only pharmacokinetics, there are an increasing number of cases where clarifying the relationships between pharmacokinetics and efficacy/safety data. Furthermore, PK-PD analysis has been applied to a growing range of drug development program, for example designing subsequent clinical studies using the modeling and simulation technique. The value and applied cases of PK-PD modeling and simulation in drug development have been discussing past several years, and the regulatory bodies and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) have published related documents and guidelines. The integration of information obtained during pre-clinical and early-phase clinical development and application of PK-PD modeling and simulation to a clinical drug development program is thought to be one of the powerful and scientific approaches for planning high-quality, speedy and cost-effective drug development program. However, it is a newly emerging approach especially in clinical drug development, therefore building multi-disciplinary teams, educating/training the professionals, collecting experiences to make database and intensive communication among different professionals are essential. This article reviews the current situation of this approach in Japan and regulatory point of view of the role of PK-PD modeling and simulation in drug development and approval.