仿制药在精神药物治疗中的有效性。

Essential psychopharmacology Pub Date : 2005-01-01
Richard Kumet, Alan J Gelenberg
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引用次数: 0

摘要

为了获得FDA的批准,仿制药必须证明生物等效性,即能够达到与它们所基于的创新药物相似的血液水平。它们必须具有相同的有效成分,相同的强度,剂型和给药途径,并在严格的FDA标准下生产。由于不需要进行基本的疗效和安全性研究,它们的成本大大降低。然而,创新药物和仿制药之间以及仿制药本身之间可能存在重要差异。需要做更多的研究来建立真正的可比性。
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The effectiveness of generic agents in psychopharmacologic treatment.

In order to win FDA approval, generic drugs must demonstrate bioequivalence, namely the ability to achieve blood levels similar to those of the innovator ones on which they are based. They must have the same active ingredients, be identical in strength, dosage form, and route of administration, and be manufactured under strict FDA standards. Because basic efficacy and safety studies are not required, their cost is significantly lower. However, there can be important differences between the innovator drugs and generics, as well as among the generics themselves. More research needs to be done to establish true comparability.

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