| 摘要(英) |
The pharmacokinetics study of clinical phaseⅠ trial, the two drugs are administered as volunteers. One is test drug and the other is reference drug. Then, the drug concentrations in blood and the concentration-time profile are obtained after administration drugs. Finally, the bioequivalence of two drugs is inferenced by area under the blood concentration cruve (AUC) or maximum blood concentration ( ). Seeing that the measured values are only the function of the drug concentration-time profile, this paper constructs a multiple testing or the simultaneous confidence-intervals of the two drugs concentration-time profile by directly using the measured values under the one-compartment model in a pharmacokinetics. Next, testing whether the two drugs have bioequivalence. In this paper, besides testing the type Ⅰerror and power of bioequivalence is using a simulation study which is conducted by above two methods and the traditional AUC method, using a data to illustrate the application of these methods. |
| 參考文獻 |
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