问题 多项选择题 案例分析题

承担并参加Ⅰ期临床的生物等效性试验。

缓释、控释制剂的生物利用度与生物等效性试验中,正确的是()

A.缓释、控样制剂的生物利用度与生物等效性试验应在单次给药与多次给药两种条件下进行

B.受试者的要求及选择标准与普通制剂相同

C.多改给药双周期交叉试验的受试者例数应多于单改给药试验

D.受试缓释、控释制剂与参比缓释、控释制剂比较,AUC符合生物等效性要求,Cmax明显降低、tmax明显延退,即显示该制剂具有缓释或控释动力学特征

E.多次给药取样点的设计,应连续服药时间至少经过7个半衰期后,连续测定3天的谷浓度,以证实受试者血药浓度已达稳态。达稳态后参照单次给药采样时间点设计,测定末次给药完整血药浓度-时间曲线

答案

参考答案:A, B, E

单项选择题
完形填空
完形填空(共20小题;每小题1.5分,满分30分)
阅读下面短文,从短文后所给各题的四个选项(A、B、C、D)中,选出可以填入空白处的最佳选项。
When my children were small, the toughest part of the day was getting to work. There were diapers(尿布), formula(奶粉),  36  of clothes to worry about for the children. There was their breakfast, and I must  37  they were clean and ready for the day. It was pretty chaotic(混乱的). I have always been one to  38  more about making sure everyone else had what they needed than to take care of myself. 39 , I had my clothing and my packed lunch set out so that I could quickly get ready and then turn my  40  back to getting the children ready.
I tried to keep my  41  pretty easy in the morning. There just wasn’t time, but that was OK as long as I kept moving. I would manage a  42  look at myself in the full-length mirror just before I  43  out the door.
Once a week we had management team  44  and it was important to be there on time and to appear relaxed and  45 . We would go around the conference table, each  46  on successes and areas of concern. When it came around to my  47 , all eyes would be on me as I had my chance to brag(自夸) on my programs and increasing  48 .
I thought I was pretty  49  at playing the role of the cool, calm, collected program manager 50  one week I arrived at one of these management team meetings and as the  51  went around the table, getting to me. There were  52  looks on the faces of the others looking at me. I started to feel a little  53  as that “ what’s going on?”  54  grew more intense. My closest colleague started doing this strange nodding thing in my direction. It was then that I  55  that I had my dress on inside-out.
小题1:
A.purchase
B.changes
C.storage
D.choices
小题2:
A.make sure
B.take care
C.help out
D.work out
小题3:
A.check
B.speak
C.find
D.worry
小题4:
A.Eventually
B.Actually
C.Fortunately
D.Hopefully
小题5:
A.attention
B.way
C.devotion
D.duties
小题6:
A.practices
B.interests
C.habits
D.routines
小题7:
A.last
B.quick
C.careful
D.thorough
小题8:
A.dashed
B.broke
C.burst
D.looked
小题9: A. work
B. meetings
C. spirits
C. tasks
小题10:
A.confident
B.attractive
C.firm
D.tidy
小题11:
A.fixing
B.concentration
C.reporting
D.settling
小题12:
A.place
B.turn
C.time
D.position
小题13:
A.fame
B.income
C.weight
D.numbers
小题14:
A.bad
B.smart
C.good
D.clever
小题15:
A.before
B.unless
C.until
D.though
小题16:
A.show
B.discussion
C.party
D.game
小题17:
A.angry
B.pleasant
C.curious
D.strange
小题18: A. uneasy
B. uncertain
D. unhappy
D. unfair
小题19:
A.question
B.atmosphere
C.feeling
D.doubt
小题20:
A.observed
B.realized
C.watched
D.suspected