Generic substitution: The use of medicinal products containing different salts and implications for safety and efficacy

Verbeeck, R.K. and Kanfer, I. and Walker, R.B. (2006) Generic substitution: The use of medicinal products containing different salts and implications for safety and efficacy. European Journal of Pharmaceutical Sciences, 28 (1/2). pp. 1-6. ISSN 0928-0987

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Official URL: http://dx.doi.org/10.1016/j.ejps.2005.12.001

Abstract

In their quest to gain early entry of new generic products into the market prior to patent expiration, one of the strategies pursued by generic drug product manufacturers is to incorporate different salts of an approved active pharmaceutical ingredient (API) in a brand company's marketed dosage form and subject such dosage forms to bioequivalence assessment. These initiatives present challenges to regulatory authorities where the decision to approve bioequivalent products containing such pharmaceutical alternatives must be considered in the light of safety and efficacy, and more particularly, with respect to their substitutability. This article describes the various issues and contentions associated with the concept of pharmaceutical alternatives, specifically with respect to the uses of different salts and the implications for safety, efficacy and generic substitution.

Item Type:Article
Additional Information:Commentary
Uncontrolled Keywords:Generic substitution; Bioequivalence; Pharmaceutical equivalence; Therapeutic equivalence; Pharmaceutical alternative
Subjects:Y Unknown > Subjects to be assigned
Divisions:Faculty > Faculty of Pharmacy
ID Code:797
Deposited By: Mrs Eileen Shepherd
Deposited On:27 Aug 2007
Last Modified:06 Jan 2012 16:19
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