Excel计算特殊制剂的群体生物等效性  

Excel Calculates the Population Bioequivalence of Special Preparations

作　　者：姚青 刘莹 王晓芳 高宁 王苗 YAO Qing;LIU Ying;WANG Xiao-fang;GAO Ning;WANG Miao(Leadingpharm Medical Technology Development Co.,Ltd.,Beijing 100094,China)

机构地区：[1]新领先医药科技发展有限公司,北京100094

出　　处：《中国药物评价》2023年第4期332-337,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:根据美国FDA颁布的布地奈德混悬液相关指导原则,利用Excel软件计算特殊制剂的体外群体生物等效性。方法:根据美国FDA中布地奈德混悬液群体生物等效性评价指导原则,以指导原则中布地奈德粒径数据为基础,使用Excel软件中函数公式计算其群体生物等效性结果,并与指导原则中结果进行比较。结果:Excel软件计算布地奈德混悬液的群体生物等效性结果与指导原则中结果完全一致,以参比制剂确定检测参数的群体生物等效性,H_(ηR)<0,受试制剂与参比制剂满足生物等效,二者疗效与安全性一致。结论:特殊制剂的体外群体生物等效性评价至关重要,在无其他专业软件情况下,Excel软件可实现快速、准确地计算特殊制剂的体外群体生物等效性。Objective:According to the guidelines of budesonide suspension issued by FDA,the bioequivalence of special preparations in vitro was calculated by Excel software.Methods:According to FDA guiding principle of population bioequivalence evaluation of budesonide suspension,based on the particle size data of budesonide in the guiding principle,the population bioequivalence results were calculated by using the function formula in Excel software,and compared with the results in the guiding principle.Results:The results of population bioequivalence of budesonide suspension calculated by Excel software are completely consistent with those in the guiding principles.The reference preparation is used to determine the population bioequivalence of the test parameters,with H_(ηR)<0.The tested preparation and the reference preparation are bioequivalent,and their efficacy and safety are consistent.Conclusion:It is very important to evaluate the bioequivalence of special preparations in vitro.Without professional software,Excel software can quickly and accurately calculate the bioequivalence of special preparations in vitro.

关 键 词：群体生物等效性 特殊制剂 EXCEL软件 布地奈德混悬液 

分 类 号：R927[医药卫生—药学]