Ereshefsky L, Jann M W, Saklad S R, Davis C M
J Clin Psychiatry. 1986 Sep;47 Suppl:6-15.
The evolution of the federal government's role in the regulation and evaluation of generic psychotropic medications is described. To place many of the methodologic bioequivalence issues for antipsychotic agents into perspective, the pharmacokinetics of these drugs are reviewed. Appropriate methodologies for studying the pharmacokinetics and pharmacodynamics of psychotropic drugs are in early developmental stages. Many of the issues relating to bioequivalence of generic products will not be resolved until a better understanding of these factors is developed.
本文描述了联邦政府在通用精神药物监管和评估方面角色的演变。为了正确看待抗精神病药物的许多方法学生物等效性问题，本文回顾了这些药物的药代动力学。研究精神药物药代动力学和药效学的适当方法尚处于早期发展阶段。在更好地理解这些因素之前，许多与通用产品生物等效性相关的问题将无法得到解决。
