Northeast Mental Health Centre, North Bay, Ontario Canada P1B 8L1.
J Clin Pharmacol. 2010 May;50(5):531-5. doi: 10.1177/0091270009347871. Epub 2010 Jan 20.
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.
本研究前瞻性评估了一组随机从氯氮平转换为氯氮平仿制药（Gen-Clozapine）的患者的结局。作者检查了转换前后评分量表的数据。在任何基线测量中，包括精神状态和药物剂量，两组之间均无统计学显著差异。在转换为仿制药的患者组中，在 6 个月监测期结束时，全球评估量表评分显著增加。在继续使用氯氮平的患者组中，在监测期末发现 32 项行为和症状识别量表评分显著下降。本研究结果表明，从氯氮平转换为 Gen-Clozapine 确实确实实现了生物等效性。
