药品可互换性评价的新标化转换准则

本文对仿制药的生物等效性和相似性评价的现有准则进行了综述。这些准则包括平均生物等效性、总群体生物等效性和个体生物等效性(IBE),以及近期提出的关于高个体差异药品的"标化转换均值生物等效性(SABE)"等。除此之外,随着对个体生物等效性(IBE)的扩展和标化转换均值生物等效性(SABE)评价法的建立,本文也提出了药品可互换性的新的评价准则。本文采用数值型研究对该新准则的应用进行了论证。该评价准则除用于仿制药品的可互换性评价外,也可用于评价生物类似制品可互换性评价。

Criteria are reviewed for the assessment of bioequivalence and biosimilarity of generic drug products.The criteria include those for average bioequivalence, for population and individual bioequivalence(IBE), and a recently proposed scaled average bioequivalence(SABE)criterion for highly variable drugs.In addition, extending an idea of IBE and the development of SABE, a new criterion for the assessment of interchangeability is proposed.A numerical study was conducted to illustrate the use of the proposed criterion.In addition to the assessment of drug interchangeability of generic drug products, the proposed criterion can be applied to the evaluation of drug interchangeability of biosimilar products.

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