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1、 Unit NineNonclinical Development of Biopharmaceuticals 生物药物Part four vIn addition to the PK assay(or mass assay),the activity assay(bioassay)is particularly useful for measuring the neutralizing activity of an ADA,although it was originally developed to measure product efficacy(e.g.for product rele
2、ase).vActivity assays might be performed in vitro(often human-cell-line based techniques)or in vivo(animal models).v虽然活性分析(生物检定)最初被开发用于测定产品药效(例如，药物释放)，但除了应用于药代分析(或质谱分析)外，它还特别适用于检测ADA的中和作用。v活性分析可在体外(常使用人类细胞系)或体内(动物模型)进行。vThese assays might suffer from lack of specificity owing to the potentially conf
3、ounding influence of substances that modulate the biological activity of the compound of interest.vThey are,however,the only way to determine whether a protein is still intact and active,which cannot be measured by a usual PK assay.v由于对目标化合物的生物活性具有调节作用的某些物质的干扰因素，这些检测方法可能缺乏特异性。v然而它们是唯一能够测定蛋白质是否仍然完整和具
4、有活性的方法，而这些无法通过“常规的”PK分析进行判断。vHow to Estimate Safety Risks of Biologics in Nonclinical Development?在非临床研究中如何评价生物制品的安全性风险?vThe objectives of the nonclinical safety program for biologics are similar to those for small molecule drugs(SMDs):to recognize potential toxicities(hazard identification and char
5、acterization,and risk assessment),to identify appropriate parameters for clinical monitoring(e.g.biomarkers)and to contribute to first-in-human dose(FIH)selection.v生物制品非临床安全性研究的目的与小分子药物(SMDs)相似：识别出潜在毒性(危害识别和鉴定，风险评估)，为临床监测确定恰当的参数(如，生物标记)，并帮助选择人体首次给药剂量(FIH)。vThis also includes assessing the limitation
6、s of nonclinical studies in predicting safety issues for the human situation.vNevertheless,the nonclinical program has to be designed for clinical decision-making.vThe program for biologics,however,is often different from SMD programs because of the nature of the therapeutic protein,its species specificity and its immunogenicity.v也包括评价非临床研究在预测人体用药安全性方面的不足v而且，非临床研究计划必须为临床决策而进行设计。v但是，由于治疗用蛋白质的性质、它的种属特异性及其免疫原性，生物制品的研究计划常不同于SMD。