药学英语药学英语 (29).pptVIP

Unit Nine Nonclinical Development of Biopharmaceuticals 生物药物 Part three Assay Types Used in Nonclinical Development of Biologics 生物制品非临床研究中使用的分析类型 When developing a PK assay strategy, the needs of the nonclinical and clinical development program have to be considered, such as sensitivity of the assay based on nonclinical and estimated clinical dose, planed combination treatments, estimated target levels, pharmacokinetics pharmacodynamics (PK/PD) modeling approaches and so on. 当研究一种PK分析策略时，必须考虑非临床和临床研发项目的需要，例如基于非临床剂量和估算的临床剂量确定分析方法的敏感性、计划的联合治疗方案、估算的靶点浓度、PK/PD的建模