alexa Bioequivalence of Generic Drugs Commercialised on the C
ISSN: 2329-6631

Journal of Developing Drugs
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Research Article

Bioequivalence of Generic Drugs Commercialised on the Canadian Market

Eric Trudel1*, Marc Parent2,3 and André Côté4

1Faculty of Neuroscience, Montreal General Hospital, R2-103, McGill University, 1650 Cedar, Montreal, QC, Canada

2Faculty of Pharmacy, Laval University, Pavillon Ferdinand-Vandry 1050 avenue de la Medecine, Quebec, QC, Canada

3Pharmacy Department, CHU de Québec, Hôpital Saint-François d’Assise 10, rue de l’Espinay, Quebec, QC, Canada

4Faculty of management, Laval University, Pavillon Palasis-Prince 2325 rue de la Terrasse, Quebec, QC, Canada

*Corresponding Author:
Dr. Eric Trudel
Faculty of Neuroscience
Montreal General Hospital
Room R2-103, McGill University
1650 Cedar, Montreal, QC
Canada, H3G 1A4
Tel: 514-934-1934
E-mail: [email protected]

Received date: January 22, 2016; Accepted date: February 09, 2016; Published date February 15, 2016

Citation: Trudel E, Parent M, Côté A (2016) Bioequivalence of Generic Drugs Commercialised on the Canadian Market. J Develop Drugs 5:150. doi:10.4172/2329-6631.1000150

Copyright: © 2016 Trudel E, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

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.

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