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The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology
Panos Macheras1,2, Athanasios A Tsekouras3,4, Sergio Sánchez-Herrero5,6
1Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece. macheras@pharm.uoa.gr.
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.
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