Safety and efficacy of generic drugs with respect to brand formulation.

J Pharmacol Pharmacother

Department of Health Science, Regional Center on drug information, Mater Domini University Hospital, Italy and Chair of Pharmacology, School of Medicine, University of Catanzaro, Italy.

Published: December 2013

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3853662PMC
http://dx.doi.org/10.4103/0976-500X.120972DOI Listing

Publication Analysis

Top Keywords

generic drugs
16
brand formulation
8
generic
5
safety efficacy
4
efficacy generic
4
drugs
4
drugs respect
4
respect brand
4
formulation generic
4
drugs equivalent
4

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!