{"title":"MIDD in Japan– Implementations, challenges and opportunities","authors":"Mayumi Hasegawa, Shinichi Kijima","doi":"10.1016/j.addr.2025.115553","DOIUrl":null,"url":null,"abstract":"In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches as the rationale for optimal dose decision and modeling outputs have supported better characterizing the risk–benefit profile of a drug by accelerating development period and regulatory-approval pathways. Three primary guidelines on pharmacometric analysis tools issued in Japan between 2019 and 2020 function as a shared communication medium between pharmaceutical companies and the regulatory agency in Japan and have contributed to increasing number of MIDD applications embedded into new drug application documents. This review article describes how the Pharmaceuticals and Medical Devices Agency have been promoting the adoption of modeling and simulation and how MIDD applications have been implemented in Japan by introducing multiple case studies. The intent is to share the knowledge and to promote the harmonization of regulations globally for accelerating the appropriate utilization of MIDD tools and implementation of various new technologies. (149 words)","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"21 1 1","pages":""},"PeriodicalIF":15.2000,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advanced drug delivery reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.addr.2025.115553","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches as the rationale for optimal dose decision and modeling outputs have supported better characterizing the risk–benefit profile of a drug by accelerating development period and regulatory-approval pathways. Three primary guidelines on pharmacometric analysis tools issued in Japan between 2019 and 2020 function as a shared communication medium between pharmaceutical companies and the regulatory agency in Japan and have contributed to increasing number of MIDD applications embedded into new drug application documents. This review article describes how the Pharmaceuticals and Medical Devices Agency have been promoting the adoption of modeling and simulation and how MIDD applications have been implemented in Japan by introducing multiple case studies. The intent is to share the knowledge and to promote the harmonization of regulations globally for accelerating the appropriate utilization of MIDD tools and implementation of various new technologies. (149 words)
期刊介绍：
The aim of the Journal is to provide a forum for the critical analysis of advanced drug and gene delivery systems and their applications in human and veterinary medicine. The Journal has a broad scope, covering the key issues for effective drug and gene delivery, from administration to site-specific delivery.
In general, the Journal publishes review articles in a Theme Issue format. Each Theme Issue provides a comprehensive and critical examination of current and emerging research on the design and development of advanced drug and gene delivery systems and their application to experimental and clinical therapeutics. The goal is to illustrate the pivotal role of a multidisciplinary approach to modern drug delivery, encompassing the application of sound biological and physicochemical principles to the engineering of drug delivery systems to meet the therapeutic need at hand. Importantly the Editorial Team of ADDR asks that the authors effectively window the extensive volume of literature, pick the important contributions and explain their importance, produce a forward looking identification of the challenges facing the field and produce a Conclusions section with expert recommendations to address the issues.
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