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Jun Li
Faculté de Pharmacie, Université de Montréal, Montréal, Canada
Publications
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Research Article
Model-Based Elaboration of a Limited Sampling Strategy in the Bioequivalence Assessment of Highly Variable Dabigatran
Author(s): Cassandre Legault and Jun Li*
Background: The bioequivalence (BE) assessment of generic (Test) and brand name (Reference) formulations of drugs with steep exposure-response relationships exhibiting high pharmacokinetic (PK) variability such as dabigatran represent an expensive challenge for pharmaceutical companies. Supported by the population pharmacokinetics (pop-PK) approach, the present article investigates modelling potential to assess BE using a reduced number of blood samples. Methods: Pop-PK models for the Reference and Test formulations were developed retrospectively using standard modeling techniques for a BE study of dabigatran. Reduced sampling scenarios were selected and the developed pop- PK models were refitted on each dataset for the respective formulations. These models were simulated to generate virtual PK profiles to be tested with the standard BE crit.. View more»