药品可互换性评价的新标化转换准则(英文)

A new scaled criterion for drug interchangeability

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 interchange- ability of generic drug products, the proposed criterion can be applied to the evaluation of drug interchangeability of biosimilar products.