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。 This review summarizes existing guidelines for evaluating the bioequivalence and similarity of generic drugs. These guidelines include mean bioequivalence, total population bioequivalence, and individual bioequivalence (IBE), as well as the recently proposed “Standardized Consensus Bioequivalence (SABE)” for high individual difference drugs Wait. In addition, with the development of individual bioequivalence (IBE) and the establishment of standardized conversion bioequivalence (SABE) method, this paper also proposed a new evaluation criteria for drug interchangeability. This paper uses numerical research to demonstrate the application of this new standard. In addition to its use for evaluation of interchangeability of generic drugs, this evaluation criterion can also be used to evaluate the interchangeability of biological analogues.