Elaboration d'un protocole pharmacocinétique lors d'une étude de bioéquivalence : application à l'amoxicilline comprimé 1g

Abstract

Before a generic drug can be dispensed, the marketing authorization holder must scientifically demonstrate that its product is bioequivalent to the reference drug. This bioequivalence is demonstrated by clinical trials designed to compare the in vivo behavior of a generic drug with that of the reference drug after administration to healthy or sick subjects. In the absence of harmonized international regulations on bioequivalence studies, each country or regional organization has drawn up its own regulations and recommendations. This work was carried out as part of a dissertation and is based on the establishment of a pharmacokinetic protocol for a bioequivalence study of amoxicillin 1g, where we highlighted the essential points of a pharmacokinetic protocol, which are : bioequivalence study design, investigational products, volunteer selection criteria, randomization plan, water and food administration conditions, adequate washout duration, sampling procedures, chemical entity to be analyzed and, finally, the most important pharmacokinetic parameters in a bioequivalence study. These essential points were then addressed by analyzing the various recommendations concerning the bioequivalence of amoxicillin 1g issued by different authorities (WHO, FDA). At the end, we compared the specific recommendations of these authorities with the general recommendations of the various authorities governing bioequivalence studies (EMA, WHO, FDA, Health Canada, Algeria). We found that all the points addressed in our pharmacokinetic protocol for amoxicillin 1g are treated in the same way, on the whole, whatever the authority followed, apart from a few differences which do not affect the quality of our protocol.