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生物等效性研究(BioequivalenceStudy)_计算生物学_科研数据集.pdf
生物等效性研究(Bioequivalence Study )
数据摘要:
Fourteen healthy male volunteers were allocated randomly to a
two-period crossover design receiving one of two treatment sequences
(A,B or B,A) where A and B are a new and an established manufacturing
process, respectively, of a two-component combination drug. A five to 10
day washout period separated the treatment periods.
The pharmacokinetic variables area under the plasma concentration curve
(AUC), maximum plasma level (Cmax), and time of maximum plasma
level (Tmax) were calculated for each subject from plasma concentrations
assayed at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7 and 8 hours post dosing on the
fourth (last) day of each treatment period. The pharmacokinetic
calculations were performed for each component of the combination drug
and are present in Table 2.
中文关键词:
生物等效性研究,健康男性志愿者,随机,治疗,药物,
英文关键词:
bioequivalence study,healthy male volunteer,randomly,treatment,drug,
数据格式:
TEXT
数据用途:
The data can be used for information processing.
数据详细介绍:
Some Favorite Datasets from Early Phases of Drug Research
Bioequivalence Study
Part 1 - Table 2
Statements
Fourteen healthy male volunteers were allocated randomly to a two-period
crossover design receiving one of two treatment sequences (A,B or B,A)
where A and B are a new and an established manufacturing process,
respectively, of a two-component combination drug. A five to 10 day washout
period separated the treatment periods.
The pharmacokinetic variables area under the plasma concentration curve
(AUC), maximum plasma level (Cmax), and time of maximum plasma level
(Tmax) were calculated for each subject from plasma concentrations assayed
at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7 and 8 hours post dosing on the fourth (last)
day of each treatment period. The pharmacokinetic calculations were
performed for each component of the combination drug and are pres
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