基于生物制药特性与食品对全身药代动力学影响关系调查的调控视角。

IF 6.3 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacology & Therapeutics Pub Date : 2025-03-10 DOI:10.1002/cpt.3622

Naoko Honma, Kota Yamagishi, Yasuhisa Ideno, Ryota Takaoka, Akihiro Ishiguro

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引用次数: 0

摘要

这一观点侧重于当前和未来的监管格局在日本关于口服给药的食品效应研究。我们对新药的研究表明，被列为生物制药分类系统（BCS）第一类的药物对全身药代动力学（Cmax和AUC）的食物效应最小。这项工作将促进讨论，以完善药物开发和关于放弃使用最终配方的食品效应研究的监管框架。

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Regulatory Perspective Based on Survey of Relationship Between Biopharmaceutical Characteristics and Food Effects on Systemic Pharmacokinetics.

This perspective focuses on the current and future regulatory landscape in Japan regarding food effect studies of orally administered drugs. Our study of new drugs shows that the drugs classified as Biopharmaceutics Classification System (BCS) Class I exert minimal food effects on systemic pharmacokinetics (C_max and AUC). This work will facilitate discussions to refine drug development and regulatory frameworks regarding the waiver of food effect studies using final formulations.

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来源期刊

Clinical Pharmacology & Therapeutics 医学-药学

CiteScore

12.70

自引率

7.50%

发文量

290

审稿时长

2 months

期刊介绍： Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.