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Generic drugs in glaucoma therapy, a new reality to deal with

机译:青光眼治疗中的非专利药物,应对的新现实

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Generics are named 'equivalent'. This is expected to (i) increase physicians' confidence in this class of products and (ii) to reinforce the concept that no difference exists between generics and the brand. Registering a drug as 'generic' means that the generic is endorsing 'some' but not 'every' feature of the originator. Let's start considering, for example, the 'bioavailability'.Bioavailability indicates the blood concentration of the drug over the time elapsing from its entry into the bloodstream until its elimination. The curve drawn by the concentration/time diagram is limiting an area, the so called area under the curve (AUC). The AUC is adopted as a parameter to compare a generic with its brand. The present regulations allow a generic to have a bioavailability within +- 20% of the brand's one.
机译:泛型被称为“等效”。预计这将(i)增强医师对此类产品的信心,并(ii)加强仿制药与品牌之间没有区别的观念。将药物注册为“仿制药”意味着该仿制药认可了原始药物的“某些”特征,而不是“所有”特征。例如,让我们开始考虑``生物利用度''。生物利用度表示药物从进入血液到消灭这段时间的血药浓度。浓度/时间图绘制的曲线限制了面积,即曲线下方的面积(AUC)。采用AUC作为参数来比较仿制药与其品牌。目前的法规允许仿制药的生物利用度在该品牌的生物利用度的±20%之内。

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