有限吸收时间概念指导模型助力临床药理学中药物及仿制药的研发。
The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology.
作者信息
Macheras Panos, Tsekouras Athanasios A, Sánchez-Herrero Sergio, Kosmidis Kosmas
机构信息
Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.
PharmaInformatics Unit, ATHENA Research Center, Athens, Greece.
出版信息
Pharm Res. 2025 Jun 5. doi: 10.1007/s11095-025-03878-4.
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.
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.
目的
展示有限吸收时间（F.A.T.）概念纳入药物研发计划、仿制药研发与评估的意义，并探讨监管方面的影响。
方法
使用基于F.A.T.的相关模型重新审视和重新分析已发表的药代动力学数据。
结果
比较新旧吸收指标，结果表明基于F.A.T.的指标具有明显优势和更高准确性。
结论
所提出的方法可成功应用于药物/仿制药研发的各个阶段，并指导其策略及相关监管框架的变革。
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