Objective To study the sample size calculation of bioequivalence test in clinical trial.
目的研究临床试验中等效性检验的样本量的计算问题。
METHODS the bioequivalence test of cefixime done by the first affiliated of China Medical University was analyzed by the traditional method and statistics similarity method.
方法用中国医科大学附属第一医院承担的头孢克肟生物等效性试验作为范例分析，计算了传统生物等效性检验和数理相似性检验。
CONCLUSION the results of variance analysis and two one-side t test showed that the two formulations were of bioequivalence.
结论方差分析和双向单侧t检验结果表明两种制剂具有生物等效性。
AIM: To compare efficacy of two designs and three test approaches in individual bioequivalence and estimate sample size.
目的：对两种设计方法、三种检验方法的个体生物等效性的检验效能进行比较，并估计样本含量。
The results showed that the test and the reference azithromycin granules were bioequivalence.
阿奇霉素颗粒试验和参比制剂生物等效。
The results showed that the test and the reference azithromycin granules were bioequivalence.
阿奇霉素颗粒试验和参比制剂生物等效。
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