Журнал разработки лекарств
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Bioequivalence of Generic Drugs Commercialised on the Canadian Market

Eric Trudel, Marc Parent and André Côté

Several international studies have revealed that there are deficiencies and non bioequivalencies in generic drug reports. The purpose of this study is to determine if monographs were available in both of Canada’s official languages for all generics introduced in the Canadian province of Quebec in 2012 and 2013, if the monographs contained all the required 90% confidence interval for the ratios test/reference of the bioequivalency parameters and if the generics were bioequivalent. From the list of solid oral form of generic drugs marketed in 2012 and 2013 in the Canadian province of Quebec, we downloaded the monographs of generics from Health Canada’s website. We then proceeded to gather information on monograph availability, whether they respected Health Canada’s guidelines and if they were bioequivalent. Our study revealed that in 2012, there were 254 eligible generics, 9.8% of them had no monograph available and only 47.6% were available in both of Canada’s official languages. Similarly for 2013, there were 227 eligible generics, 7.0% of them had no monograph available and only 41.0% were available in both of Canada’s official languages. Overall, only 57.09% of generics in 2012 and 65.20% of generics in 2013 were shown bioequivalent to their reference drug. This data indicates that health care professionals amongst others, lack crucial information to make a responsible decision on the use of generics.