Gottschalk L A
J Clin Psychiatry. 1986 Sep;47 Suppl:3-5.
A generic drug containing the same active ingredient as a brand name drug may not show identical clinical efficacy. There is increasing evidence that substitution of a generic for a brand name (or vice versa) drug with the expectation of similar results is problematic and that improper treatment may result. Clinical trials are needed to test generic psychoactive drugs. This paper provides guidelines for clinical situations in which problems relating to bioavailability and bioequivalence may arise, for example, in patients taking concomitant medication(s) or in chronically ill or elderly patients. In addition, the importance of knowing which assay methods are used to measure psychoactive drug blood levels in considering drug efficacy is stressed.
一种含有与品牌药相同活性成分的仿制药可能不会表现出相同的临床疗效。越来越多的证据表明，期望用仿制药替代品牌药（或反之亦然）以获得相似结果是有问题的，而且可能导致治疗不当。需要进行临床试验来测试仿制药精神活性药物。本文为可能出现生物利用度和生物等效性相关问题的临床情况提供了指导方针，例如，在服用联合用药的患者中，或在慢性病患者或老年患者中。此外，强调了在考虑药物疗效时了解用于测量精神活性药物血药浓度的检测方法的重要性。
