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Generic substitution of antiepileptics: need for a balanced view
There is considerable interest and debate concerning the place of generic substitution, especially relating to antiepileptic drugs (AEDs). Sadly, one of the causes of the ongoing debate is confusion, often intentionally fueled by the pharmaceutical industry among health professionals and patients regarding the regulatory determination of bioequivalence. Few understand the correct definition. It is often erroneously stated that to be considered bioequivalent there is an allowed difference in the extent and rate of absorption of 80% to 125% between a generic drug product and the branded standard. This is false and implies there is a wide leniency allowed, with varying clinical outcomes probable. This myth needs to be countered to reassure the safety of patients. A balanced review of the issues surrounding the generic substitution of AEDs is presented.
Funding
Department of Health and Aged Care
History
Publication title
Cns SpectrumsVolume
16Issue
8Pagination
579-585ISSN
1092-8529Department/School
School of Pharmacy and PharmacologyPublisher
M B L CommunicationsPlace of publication
United StatesRights statement
Copyright © 2011 MBL CommunicationsRepository Status
- Restricted