2021 Volume 11 Issue 1 Pages 83-90
In recent years, population pharmacokinetic and pharmacodynamic analysis has been increasingly utilized in drug development when considering pharmacokinetics, pharmacodynamics and exposure-response relationships. The population approach is useful for evaluating the pharmacokinetic profile of patients, comparing different population groups (e. g., between different ethnic groups), and to obtain the appropriate dosage and administration of drug. However, there was no guideline showing basic principles and detailed considerations for population pharmacokinetic and pharmacodynamic analysis in Japan. Thus, the “Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis” has been developed in consideration of the latest accumulated scientific knowledge. In this article, we present an overview of the guideline and a development process of this guideline from standpoint as regulatory members in an industry-public sector-academia research group.
