Evaluating the Feasibility of Use of a Foreign Reference Product for Generic Drug Applications: A Retrospective Pilot Study

Abstract

Although this retrospective analysis only included a few drugs and product formulation types, i.e., immediate release, delayed release, and orally disintegrating tablet, these preliminary results suggest that using a foreign reference product in BE studies for generic drug applications could be a feasible approach, but with some restrictions: comparable dissolution profiles, same innovator company, same size, weight, and type of coating as the domestic reference product, etc. Further investigations for other complex formulations are required.

Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia

“…This study demonstrates that the bioavailability of these 4 generic AICs have been adopted as a useful tool for assessing bioequivalence between generic products and their switchability, [16][17][18][19][20][21] as well as for comparing originator products from different markets that have previously been shown to be bioequivalent with the same generic product. 29 To our knowledge, this is the first study to compare clopidogrel generic products. AICs method utilises the publicly available summarized results from bioequivalence studies and, consequently, it is the simplest and the most appropriate method when only 2 interventions are to be compared indirectly.…”

“…AICs have been adopted as a useful tool for assessing bioequivalence between generic products and their switchability, as well as for comparing originator products from different markets that have previously been shown to be bioequivalent with the same generic product . To our knowledge, this is the first study to compare clopidogrel generic products.…”