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生物制品的非临床研究较化学药物有明显特殊性。由于生物制品很难完全确定其结构,具有免疫原性,生产过程容易受到污染等原因,进行非临床试验前需进行药学的安全性试验、鉴定试验、纯度试验、效能试验,确保产品药学特征的一致性,然后根据生物制品的特点来选择合适动物种属来开展试验。药效学、毒理学和药动学试验中需重点关注产品的生物活性、免疫原性/毒性和体内过程研究。鉴于动物种属差异对非临床研究结果有重要影响,根据非临床研究结果外推人体试验时应更加谨慎。
Non-clinical research of biological products is more specific than chemical drugs. Because biological products is difficult to fully determine its structure, with immunogenicity, the production process is easily contaminated and other reasons, the need for non-clinical trials before the safety of pharmaceutical tests, identification tests, purity tests, performance tests to ensure that the product pharmacological characteristics Consistency, and then select the appropriate animal species according to the characteristics of biological products to carry out experiments. Pharmacodynamic, toxicological and pharmacokinetic studies need to focus on the biological activity of the product, immunogenicity / toxicity and in vivo process studies. Given that animal species differences have important implications for nonclinical studies, extrapolation of human trials based on nonclinical findings should be more cautious.
