EUFEPS Seminar: FROM THE FINITE ABSOPRTION TIME (FAT) CONCEPT TO THE PHYSIOLOGICALLY BASED FINITE TIME PHARMACOKINETIC (PBFTPK) MODELS.

We want to invite you to the virtual EUFEPS Seminar on July 6, 2022 from 2 pm - 6 pm CEST.

The seminar will cover the following topic: "FROM THE FINITE ABSOPRTION TIME (FAT) CONCEPT TO THE PHYSIOLOGICALLY BASED FINITE TIME PHARMACOKINETIC (PBFTPK) MODELS."

Scientific Program

Summary

This seminar is intended for Academics/students or scientists working in Academia, pharmaceutical industries, regulatory agencies, and contract research organizations.

The Physiologically Based Finite Time Pharmacokinetic (PBFTPK) models were built on two principles i) drugs are absorbed passively for a finite period of time, τ and ii) time absorption constrains linked with the gastrointestinal transit times of drug in the stomach, the small intestines and the colon were applied. The application of PBFTPK models to the analysis of several case studies for data set analyses using the PBFTPK software will be presented. The PBFTPK software used in all model fittings relies on user defined functions in Igor programming environment.  The implications of Finite Absorption Time (FAT) associated with bioavailability, bioequivalence (BE), biowaivers and IVIVC will be presented. The current BE approach based on the traditional metrics using (AUC)_0-∞ and C_max will be questioned. Analysis of a bioequivalence pilot study of axitinib with two tests and one reference formulation under the prism of FAT will be presented. Finally, the synergy between the two modeling approaches PBPK and PBFTPK is presented. This synergy can lead to both improvements on initial parameterization of PBPK/PBBM models but to also expand mechanistic oral absorption concepts to more traditional pharmacometrics applications.

Relevant publications

1. P MACHERAS. On an unphysical hypothesis of Bateman equation and its implications for pharmacokinetics. Pharmaceutical Research. (2019) 36:94 https://doi.org/10.1007/s11095-019-2633-4
2. MACHERAS, P. CHRYSSAFIDIS. Revising Pharmacokinetics of Oral Drug Absorption: I Models Based on Biopharmaceutical/Physiological and Finite Absorption Time Concepts. Pharm Res 37, 187 (2020). https://doi.org/10.1007/s11095-020-02894-w (cover page of the issue). Erratum/ Pharm Res 37, 206 (2020). https://doi.org/10.1007/s11095-020-02935-4
3. CHRYSSAFIDIS, A. A. TSEKOURAS, P. MACHERAS. Revising Pharmacokinetics of Oral Drug Absorption: II Bioavailability-Bioequivalence Considerations, Pharmaceutical Research38, 1345–1356 (2021) [DOI: 10.1007/s11095-021-03078-w]
4. A. TSEKOURAS, P. MACHERAS. Re-examining digoxin bioavailability after half a century: Time for changes in the bioavailability concepts. Pharmaceutical Research (2021) [DOI: 10.1007/s11095-021-03121-w]
5. CHRYSSAFIDIS, A. A. TSEKOURAS, P. MACHERAS Re-writing oral pharmacokinetics using physiologically based finite time pharmacokinetic (PBFTPK) models. Pharmaceutical Research. 2022;39:. https://doi.org/10.1007/s11095-022-03230-0.
6. Ν. ALIMPERTIS, A. A. TSEKOURAS, P. MACHERAS Revising the assessment of bioequivalence in the light of finite absorption time (FAT) concept: The axitinib case. Submitted to 30^th PAGE meeting Ljubljana 28 June-1 July , 2022
7. WU, A. A. TSEKOURAS, P. MACHERAS, F. KESISOGLOU. Physiologically based pharmacokinetic models under the prism of the finite absorption time concept. (Submitted)
8. A. TSEKOURAS, P. MACHERAS. Columbus' egg: Oral drugs are absorbed in finite time. (Submitted)

Registration and fees:

A registration with the following fees is needed for this event:

Register here!