The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology.

IF 3.5 3区医学 Q2 CHEMISTRY, MULTIDISCIPLINARY

Pharmaceutical Research Pub Date : 2025-06-05 DOI:10.1007/s11095-025-03878-4

Panos Macheras, Athanasios A Tsekouras, Sergio Sánchez-Herrero, Kosmas Kosmidis

引用次数: 0

Abstract

Purpose: To show the implications of the incorporation of the Finite Absorption Time (F.A.T.) concept in drug development plans and in generics development and assessment and to examine regulatory implications.

Methods: Reexamining and reanalyzing published pharmacokinetic data using the pertinent models that are based on F.A.T.

Results: Comparing absorption metrics, old and new ones, shows distinct advantages and better accuracy for those based on the F.A.T.

Concept:

Conclusion: The proposed approaches can be applied successfully in all phases of drug/generics development and guide changes in their strategy and in the relevant regulatory framework.

查看原文本刊更多论文

有限吸收时间概念指导模型指导临床药理学药物和仿制药开发。

目的：显示有限吸收时间（F.A.T.）概念在药物开发计划和仿制药开发和评估中的影响，并检查监管影响。方法：使用基于f.a.t的相关模型对已发表的药代动力学数据进行重新检查和再分析。结果：比较新旧两种吸收指标，发现基于f.a.t的吸收指标具有明显的优势和更高的准确性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Pharmaceutical Research 医学-化学综合

CiteScore

6.60

自引率

5.40%

发文量

276

审稿时长

3.4 months

期刊介绍： Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.