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

Verbeeck, R K; Kanfer, Isadore; Walker, Roderick B

Title: Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy
Creator: Verbeeck, R K
Creator: Kanfer, Isadore
Creator: Walker, Roderick B
Date Issued: 2006
Date: 2006
Type: text
Type: Article
Identifier: vital:6445
Identifier: http://hdl.handle.net/10962/d1006632
Description: 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.
Format: 14 pages
Language: English
Relation: 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. Available: http://dx.doi.org/10.1016/j.ejps.2005.12.001

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Walker, Roderick Bryan (Prof)

Kanfer, Isadore (Prof)

RU Department of Pharmacy

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