综合分析选择题 某临床试验机构进行罗红霉素片仿制药的生物等效性评价试验,单剂量(250mg)给药。经24名健康志愿者试验,测得主要药动学参数如下表所示。 经统计
A
供试制剂的相对生物利用度为105.9%,超过100%,可判定供试制剂与参比制剂生物不等效 B
根据AUC<img border="0" alt="" src="https://img.weimei168.com/uploads/upimg/20230210/14474352_0_3.gif">和C<img border="0" alt="" src="http://www.jinkaodian.com/CL.ExamWebService/image/99/14474352_0_4.gif">的试验结果,可判定供试制剂与参比制剂生物等效 C
根据t<img border="0" alt="" src="https://img.weimei168.com/uploads/upimg/20230210/14474352_0_5.gif">和t<img border="0" alt="" src="http://www.jinkaodian.com/CL.ExamWebService/image/99/14474352_0_6.gif">的试验结果,可判定供试制剂与参比制剂生物等效 D
供试制剂与参比制剂的C<img border="0" alt="" src="https://img.weimei168.com/uploads/upimg/20230210/14474352_0_7.gif">均值比为97.0%,可判定供试制剂与参比制剂生物不等效 E
供试制剂与参比制剂的t<img border="0" alt="" src="https://img.weimei168.com/uploads/upimg/20230210/14474352_0_8.gif">均值比为91.7%,可判定供试制剂与参比制剂生物不等效