药学英语药学英语 (27).pptVIP

Unit Nine Nonclinical Development of Biopharmaceuticals 生物药物 Part four In 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 release). Activity assays might be performed in vitro (often human-cell-line based techniques) or in vivo (animal models). 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。 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。 These assays might suffer from lack o