小中大
不知道你的生物制品具体是什么。
——总体原则是：
（四）对药理毒理研究资料的说明
1.鉴于生物制品的多样性和复杂性，药理毒理方面的资料项目要求可能并不适用于所有
的治疗用生物制品。注册申请人应基于制品的作用机制和自身特点，参照相关技术指导原则，
科学、合理地进行药理毒理研究。如果上述要求不适用于申报制品，注册申请人应在申报资
料中予以说明，必要时应提供其他相关的研究资料。
2.原则上，应采用相关动物进行生物制品的药理毒理研究；研究过程中应关注生物制品
的免疫原性对动物试验的设计、结果和评价的影响
——何为相关动物？
PRECLINICAL SAFETY EVALUATION OF
BIOTECHNOLOGY-DERIVED PHARMACEUTICALS
S6(R1)
3.3 Animal Species/Model Selection
The biological activity together with species and/or tissue specificity of many biotechnology-derived pharmaceuticals often preclude standard toxicity testing designs in commonly used species (e.g., rats and dogs). Safety evaluation programs should include the use of relevant species.
A relevant species is one in which the test material is pharmacologically active due to the expression of the receptor or an epitope (in the case of monoclonal antibodies). A variety of techniques (e.g., immunochemical or functional tests) can be used to identify a relevant species. Knowledge of receptor/epitope distribution can provide greater understanding of potential in vivo toxicity.
