Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan.

IF 2.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Tomohiro Sasaki, Takayuki Katsube, Seiichi Hayato, Shingo Yamaguchi, Jun Tanaka, Hiroki Yoshimatsu, Yushi Nakanishi, Atsushi Kitamura, Hirotaka Watase, Hideki Suganami, Nobushige Matsuoka, Chihiro Hasegawa
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Abstract

Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness and application of MIDD in Japan, the Data Science Expert Committee of the Drug Evaluation Committee in the Japan Pharmaceutical Manufacturers Association established a task force, which surveyed MIDD applications for approved products in Japan. This study aimed to reveal the trends and challenges in the use of MIDD by analyzing the survey results. A total of 322 cases approved in Japan between January 2020 and March 2022 as medical products were included in the survey. Modeling analysis was performed in approximately half of the cases (47.8% [154/322]) and formed a major basis for the selection or justification of dosage and administration in approximately one-fourth of the cases [24.2% (78/322)]. Modeling analysis/model-based dose selection was frequently conducted in cases involving monoclonal antibodies, first indication, orphan drugs, and multi-regional trials. Moreover, the survey results indicated that modeling analyses contributed to dose optimization throughout the developmental phases, including changing dose levels from phase II to phase III and dose adjustment in special populations. Japanese data were included in most cases in which modeling analysis was used for dosage selection. Thus, modelling analysis may also address ethnic factors introduced in the ICH E5 and/or E17 guidelines. In summary, this survey is useful for understanding the current status of MIDD use in Japan and for future drug development.

模型知情药物开发(MIDD)在日本药物批准监管提交中剂量选择的应用。
基于模型的药物开发(MIDD)是一种提高药物开发效率的方法。为了促进MIDD在日本的认识和应用,日本制药商协会药品评价委员会的数据科学专家委员会成立了一个工作组,对日本已批准产品的MIDD申请进行调查。本研究旨在通过对调查结果的分析,揭示MIDD使用的趋势和挑战。在2020年1月至2022年3月期间,日本共批准了322起医疗产品案例。在大约一半的病例(47.8%[154/322])中进行了建模分析,并在大约四分之一的病例(24.2%(78/322))中形成了剂量和给药选择或证明的主要依据。在涉及单克隆抗体、首次指征、孤儿药和多地区试验的病例中,经常进行建模分析/基于模型的剂量选择。此外,调查结果表明,建模分析有助于整个发展阶段的剂量优化,包括从第二阶段到第三阶段的剂量水平变化以及特殊人群的剂量调整。在使用建模分析进行剂量选择的大多数情况下,都包括了日本的数据。因此,建模分析也可以解决ICH E5和/或E17指南中引入的种族因素。总之,这项调查有助于了解MIDD在日本的使用现状和未来的药物开发。
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来源期刊
CiteScore
4.90
自引率
4.00%
发文量
39
审稿时长
6-12 weeks
期刊介绍: Broadly speaking, the Journal of Pharmacokinetics and Pharmacodynamics covers the area of pharmacometrics. The journal is devoted to illustrating the importance of pharmacokinetics, pharmacodynamics, and pharmacometrics in drug development, clinical care, and the understanding of drug action. The journal publishes on a variety of topics related to pharmacometrics, including, but not limited to, clinical, experimental, and theoretical papers examining the kinetics of drug disposition and effects of drug action in humans, animals, in vitro, or in silico; modeling and simulation methodology, including optimal design; precision medicine; systems pharmacology; and mathematical pharmacology (including computational biology, bioengineering, and biophysics related to pharmacology, pharmacokinetics, orpharmacodynamics). Clinical papers that include population pharmacokinetic-pharmacodynamic relationships are welcome. The journal actively invites and promotes up-and-coming areas of pharmacometric research, such as real-world evidence, quality of life analyses, and artificial intelligence. The Journal of Pharmacokinetics and Pharmacodynamics is an official journal of the International Society of Pharmacometrics.
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