Journal of Bioequivalence & Bioavailability

Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, 15784 Athens, Greece

Biography

Eleni Karatza currently works in the Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, 15784 Athens, Greece. His research interest includes Population modeling; Simulations.

Publications

• Research   
  Non-linear Mixed Effects Modeling and Simulation for Exploring Variability Sources in Dissolution Curves: A BCS Class II Case Example
  Author(s): Eleni Karatza* and Vangelis Karalis
  
  Purpose: Irbesartan is a BCS class II compound that exhibits pH– and buffer capacity–dependent dissolution behavior. The aim of this study was to apply non-linear mixed effects modelling on dissolution data of two immediate release products containing Irbesartan in order to characterize and quantify the sources of inter-dissolution profile variability. Methods: Nonlinear mixed effects modelling was applied to describe the dissolution curves obtained for Irbesartan in three different pH-value media (1.2, 4.5, 6.8) with two different products (reference product: Aprovel® and a generic test product). Simulations performed and the impact of inter-dissolution variability was assessed. Results: The % Irbesartan dissolved to time was found to follow a Weibull distribution. Τhe population scale paramete.. View more»
  

  DOI: 10.35248/0975-0851.20.12.406

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