The generic inequivalence of drugs.
The generic inequivalence of drugs.
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药物的通用不平等。
DOI：
10.1001/jama.1968.03150080025004
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发表时间：
1968
期刊：
影响因子：
--
通讯作者：
A. B. Varley
中科院分区：
文献类型：
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作者：
A. B. Varley
药物的通用等效性是一个语义混乱的概念。为了有意义，必须说明等效性标准。在这项简单的研究中，发现两种不同的甲苯磺丁脲制剂在化学含量和美国药典规范方面一般等同，但在患者药物可用性（血清药物水平）或治疗效果（降血糖反应）方面明显不等同。关于这一主题的声明应明确，以免术语和含义的混淆导致治疗反应的“通用不等效”。
Generic equivalence of drugs is a semantically muddled concept. To be meaningful, the criteria for equivalence must be stated. In this simple study, two different formulations of tolbutamide, both generically equivalent in terms of chemical content and specifications of the United States Pharmacopoeia , were found to be clearly not equivalent as measured by availability of drug to the patient (serum drug levels) or therapeutic efficacy (hypoglycemic response). Clarity in pronouncements on this subject should be established so that confusion in terminology and meaning does not lead to "generic inequivalence" of therapeutic response.