Does Therapeutic Equivalence Follow Bioequivalence? A Randomized Trial to Assess Clinical Effects After Switching From Clozaril to Generic Clozapine (Gen-Clozapine)

作者：Oluboka Oloruntoba; Stewart Sandra^*; Landry Suzette; Adams Susan

来源：JOURNAL OF CLINICAL PHARMACOLOGY, 2010, 50(5): 531-535.

DOI：10.1177/0091270009347871

• generic clozapine
• Clozaril
• switch
• clinical research
• disease management
• outcomes research
• psychiatry
• psychopharmacology

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.

• 出版日期2010-5
• 单位上海市精神卫生中心