Mindel J S
Surv Ophthalmol. 1976 Nov-Dec;21(3):262-75. doi: 10.1016/0039-6257(76)90124-7.
Although oral drug bioinequivalence has been attributed to a number of causes (excipients, dosage form, variation in dissolution time, and aging) less is known about bioavailability problems of topical medications in ophthalmology. Factors that can alter drug absorption from solutions (pH, partition coefficient, container impurities, contact time, etc.) are noted, and cases in which bioavailability problems should be considered as causes of therapeutic failure are discussed. Various attitudes representing pharmaceutical companies, the federal government, pharmacists, consumers and physicians toward the related problems of bioinequivalence and generic prescribing are examined. Techniques for in vivo and in vitro drug testing and for establishing uniform conditions of drug manufacture and storage can contribute to identification and minimization of bioavailability problems. A rational program based on a combination of such techniques could, ultimately, lead to establishment of the terms "generic equivalency" and "therapeutic equivalency" as synonymous.
虽然口服药物生物不等效性可归因于多种原因（辅料、剂型、溶出时间变化和老化），但对于眼科局部用药的生物利用度问题却知之甚少。文中指出了可改变溶液药物吸收的因素（pH值、分配系数、容器杂质、接触时间等），并讨论了应将生物利用度问题视为治疗失败原因的情况。研究了制药公司、联邦政府、药剂师、消费者和医生对生物不等效性和仿制药处方相关问题的各种态度。体内和体外药物测试技术以及建立统一的药物生产和储存条件有助于识别生物利用度问题并将其最小化。基于这些技术组合的合理方案最终可能会使“仿制药等效性”和“治疗等效性”这两个术语成为同义词。
