长半衰期药物无清洗期时的生物等效性研究

目的：探讨长半衰期药物（t1／2〉24h）在无清洗期时生物等效性研究中的AUC和Cmax的计算，通过无清洗期的实验数据推算出正常清洗期的数据。方法：利用SPSS软件，建立二室模型口服药物在无清洗期时的半衰期为100小时的生物等效性模型，通过优化AUC和Cmax的计算方法，降低药物残留对第二周期药物浓度的影响，进而增加AUC和Cmax的计算的精确性，最后用较精确的方法推算出正常清洗期的AUC和Cmax，利用精确的数据进行生物等效性的进一步验证。结果：在无清洗期的状态下，取样时间在大于0．8个半衰期时，平均值法计算的Auc和Cmax的结果误差小于5％，变异系数小于25％，较为精确，生物等效性研究进一步验证了这一观点。结论：在无清洗期的情况下，生物等效性研究最小的采样时间为0．8个半衰期。

Methodology on the no Washout Period Bioequivalence of Long Half-life Drugs＊

Objective： To investigate the calculation method of AUC and Cmax in long half-life drugs on no washout period bioequivalence and calculate the normal washout period data through the experimental data without washout period. Me,otis： This study established a two-compartment oral drugs bioequivalence model with no washout period taking advantage of SPSS software. It reduced the impact of drug residues in second period administered drug by optimizing the calculation method of AUC and Cmax, And then the calculate precision was increased. Finally, a more accurate calculation method was used to conjecture the normal cleaning period of the AUC and Cmax, and it would further be verified by the bioeqnivalence study. Results： In no washout period bioequivalence, the calculation results of AUC and Cmax error was less than 5 %, the variation coefficient was less than 25 % in more than 0.8 half-life sampling time. The bioequivalence result had further verified this opinion. Conclusions： In the no washout period case, bioequivalence study sampling time at least 0.8 half-life.