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。
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