基于生理的药代动力学/生物药剂学建模在制剂开发中的新兴作用

Q4 Pharmacology, Toxicology and Pharmaceutics
S. Cvijić, Jelisaveta Ignjatović, J. Parojčić, S. Ibrić
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引用次数: 3

摘要

基于计算机的(硅片)建模和仿真工具已被广泛应用于制药的不同领域。其中,基于生理的药代动力学/生物药剂学建模(PBPK/PBBM)在制剂开发中成为一个特别有用的工具。制药行业的几份报告以及关于这一主题的一些研究和评论论文表明,在过去几年中,PBPK/PBBM促进战略得到了越来越多的评价。此外,主要监管机构最近发布了关于在配方设计中使用PBPK模型的指导。在计算机中,PBPK模型可以包括不同的给药途径(口服、口服、肠外、吸入、眼内、皮肤等),尽管大多数已发表的例子是指口服药物性能的建模。为了方便PBPK建模工具的使用,几家公司已经推出了商用软件,如GastroPlus™,Simcyp™PBPK模拟器和PK-Sim®。本文重点介绍了PBPK/PBBM建模的各种应用领域,以及该方法的基本原理、优点和局限性,并通过相关实例说明建模仿真工具在配方开发的不同阶段的实际应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a particularly useful tool in formulation development. PBPK/PBBM facilitated strategies have been increasingly evaluated over the past few years, as demonstrated by several reports from the pharmaceutical industry, and a number of research and review papers on this subject. Also, the leading regulatory authorities have recently issued guidance on the use of PBPK modeling in formulation design. In silico PBPK models can comprise different dosing routes (oral, intraoral, parenteral, inhalation, ocular, dermal etc.), although the majority of published examples refer to modeling of oral drugs performance. In order to facilitate the use of PBPK modeling tools, a couple of companies have launched commercially available software such as GastroPlus™, Simcyp™ PBPK Simulator and PK-Sim®. This paper highlights various application fields of PBPK/PBBM modeling, along with the basic principles, advantages and limitations of this approach, and provides relevant examples to demonstrate the practical utility of modeling & simulation tools in different stages of formulation development.
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来源期刊
Arhiv za Farmaciju
Arhiv za Farmaciju Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
自引率
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发文量
19
审稿时长
12 weeks
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