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Does therapeutic equivalence follow bioequivalence? A randomized trial to assess clinical effects after switching from Clozaril to generic clozapine (gen-clozapine).

Author(s): Oluboka O, Stewart S, Landry S, Adams S

Affiliation(s): Northeast Mental Health Centre, North Bay, Ontario Canada P1B 8L1.

Publication date & source: 2010-05, J Clin Pharmacol., 50(5):531-5. Epub 2010 Jan 20.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

This study prospectively assessed outcomes in a group of patients who were randomly switched from Clozaril to generic clozapine (Gen-Clozapine). The authors examined data from rating scales administered before the switch and at points after the switch. There were no statistically significant differences between the groups on any baseline measures, including psychiatric status and dose of medication. In the group of patients who were switched to the generic formulation, there was a significant increase in Global Assessment Scale scores by the end of the 6-month monitoring period. In the group of patients who remained on Clozaril, a significant decrease in the 32-item Behavior and Symptom Identification Scale scores was found at the end of the monitoring period. The results of this study suggest that clinical equivalence indeed followed bioequivalence when switching from Clozaril to Gen-Clozapine.

Page last updated: 2010-10-05

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