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Purpose <p>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.</p> Methods <p>Reexamining and reanalyzing published pharmacokinetic data using the pertinent models that are based on F.A.T.</p> Results <p>Comparing absorption metrics, old and new ones, shows distinct advantages and better accuracy for those based on the F.A.T. concept.</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月5日

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

摘要

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.