臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
総説
臨床薬理分野での PBPK モデルの有効活用 ―具体例を通して学ぶ―
江本 千恵土岐 浩介松本 有毅木島 慎一中村 己貴子福田 剛史
著者情報
ジャーナル 認証あり

2020 年 51 巻 6 号 p. 331-344

詳細
抄録

The utilization of a physiologically-based pharmacokinetic (PBPK) model has become prevalent, especially in drug development by pharmaceutical companies. The regulatory agencies in the US and Europe have already issued guidelines while the Japanese agency is preparing one to support the process. To some extent, applications of PBPK modeling to assess the risk of drug-drug interaction have mainly been discussed. It has been limited to discussing other utilizations such as: 1) conducting a virtual bioequivalence study for a new formulation; 2) assessing PK changes in a Japanese population; and 3) predicting PK profiles of drugs or drug candidates in pediatric subjects. The purpose of this paper is to discuss the current status and future challenges of potential utilizations of PBPK modeling through actual practices and to share regulatory experiences on PBPK modeling in Japan. We summarize the discussions on prospects from the perspective of industry, academia, regulatory agencies, and hospitals.

著者関連情報
© 2020 日本臨床薬理学会
前の記事
feedback
Top