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药物动力学和生物药剂学研究中,数据资料的分析和阐明有赖于研究工作中临床实验和分析方法的正确设计和执行。临床实验设计应尽可能利用已有的临床前资料以确保其安全性。同样,测定体液中药物及代谢产物的分析方法也应精心设计以达到最理想的准确度和精密度。如果使用的方法不精确,可能给数据的评价和解释带入显著的误差。对进行样品分析以前,应先选择和建立分析方法,以确保能够得到精确的数据。方法的建立包括由每一分析工作者在给定的仪器上测定拟用方法的特性及应用范围。在方法建立过程中,关键是对以下特性作出评价:药物稳定性、灵敏度、选择性、回收率、线性、校正曲线的精密度和准确度,以及方法的精
In pharmacokinetics and biopharmaceutical research, the analysis and elucidation of data relies on the proper design and implementation of clinical trials and analytical methods in research. Clinical trial design should use as much preclinical data as possible to ensure its safety. Similarly, assays for the determination of drugs and metabolites in bodily fluids should be carefully designed to achieve the best possible accuracy and precision. Inaccurate methods may introduce significant errors in the evaluation and interpretation of the data. Before conducting a sample analysis, you should select and establish an analytical method to ensure accurate data is available. The establishment of the method includes the determination of the nature of the method to be used and the scope of application by each analyst on a given instrument. In the process of establishing the method, the key is to evaluate the following properties: drug stability, sensitivity, selectivity, recovery, linearity, precision and accuracy of the calibration curve, and method precision