Singh S, Sharma D R
Department of Medical Services, Panacea Biotec Ltd.
J Indian Med Assoc. 1999 Jul;97(7):292-3.
Microemulsion based cyclosporine has demonstrated better absorption with laser pharmacokinetic variability. For the clinical use of any new microemulsion based product, bioequivalence testing with existing formulation is necessary. Panimun Bioral (Test) and Sandimmun Neoral (Reference) were evaluated in different transplant centers using both volunteers as well as renal transplant patients. All these centres have reported that both products are bioequivalent. These reports offer the physician an option to convert the patients to the Test product for economic reasons.
基于微乳剂的环孢素已显示出更好的吸收，且具有较低的激光药代动力学变异性。对于任何基于微乳剂的新产品的临床应用，与现有制剂进行生物等效性测试是必要的。在不同的移植中心，使用志愿者和肾移植患者对泛明免疫生物制剂（测试产品）和新山地明（参比产品）进行了评估。所有这些中心都报告称，这两种产品具有生物等效性。这些报告为医生提供了一个选择，出于经济原因可将患者转换使用测试产品。
