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在药代动力学、生物利用度(bioavailability)与生物等效度的研究中,重要的是必须采用具有特征的且经充分合格性查证(Validated)的现代化分析方法,以获得能供满意解释的可靠数据。分析方法经常在改进,需要强调:每一种分析技术都具有自己的因药而异的特点。分析技术的适用性受研究工作最终目标的影响。用于每种药物或代谢物的分析方法,需要各自明确的合格性查证标准.当样本进行多中心分析时,必须在每个实验室对分析方法进行合格性查证,并为每个实验室提供适当的合格性查证信息,使各实验室之间的测定结果具有相互可信性。除非一
In the studies of pharmacokinetics, bioavailability and bioequivalence, it is important to have a modern and validated and validated analytical method that can be satisfactorily explained Reliable data. Analytical methods are often being improved, and it is important to emphasize that each analytic technique has its own unique drug-specific characteristics. The applicability of analytical techniques is influenced by the ultimate goal of the research work. Analytical methods used for each drug or metabolite require separate definitive eligibility verification criteria.When samples are subjected to multicenter analyzes, the analytical methods must be validated in each laboratory and provided to each laboratory Appropriate compliance verification information, so that the results of the test between laboratories with each other credible. Unless one