Objective To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes.Methods The power functions of ...Objective To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes.Methods The power functions of the Fieller-type confidence interval and the asymptotic confidence interval in crossover designs with serial-sampling data are here derived.Simulation studies were conducted to evaluate the derived power functions.Results Simulation studies show that two power functions can provide precise power estimates when normality assumptions are satisfied and yield conservative estimates of power in cases when data are log-normally distributed.The intra-correlation showed a positive correlation with the power of the bioequivalence test.When the expected ratio of the AUCs was less than or equal to 1, the power of the Fieller-type confidence interval was larger than the asymptotic confidence interval.If the expected ratio of the AUCs was larger than 1, the asymptotic confidence interval had greater power.Sample size can be calculated through numerical iteration with the derived power functions.Conclusion The Fieller-type power function and the asymptotic power function can be used to determine sample sizes of crossover trials for bioequivalence assessment of topical ophthalmic drugs.展开更多
运用内容分析法对近10年北美体育教学研究的权威学术刊物《Journal of Teaching in Physical Education》刊载的231篇文章的内容特征进行分析,发现:研究主体分布广泛并注重主体间协作,主体专业背景呈多样化;研究主题多热衷于学生性别、...运用内容分析法对近10年北美体育教学研究的权威学术刊物《Journal of Teaching in Physical Education》刊载的231篇文章的内容特征进行分析,发现:研究主体分布广泛并注重主体间协作,主体专业背景呈多样化;研究主题多热衷于学生性别、学习兴趣与动机、教师专业、职业发展、学习者特定领域学习发展、体育游戏及教师教育评估等方面;研究设计以调查和试验研究为主;研究方法多采用实验法,注重定量研究,属于定性与定量相结合的研究占多数。展开更多
基金supported by sub-project of National Major Scientific and Technological Special Project of China for ‘Significant New Drugs Development’[2015ZX09501008-004]
文摘Objective To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes.Methods The power functions of the Fieller-type confidence interval and the asymptotic confidence interval in crossover designs with serial-sampling data are here derived.Simulation studies were conducted to evaluate the derived power functions.Results Simulation studies show that two power functions can provide precise power estimates when normality assumptions are satisfied and yield conservative estimates of power in cases when data are log-normally distributed.The intra-correlation showed a positive correlation with the power of the bioequivalence test.When the expected ratio of the AUCs was less than or equal to 1, the power of the Fieller-type confidence interval was larger than the asymptotic confidence interval.If the expected ratio of the AUCs was larger than 1, the asymptotic confidence interval had greater power.Sample size can be calculated through numerical iteration with the derived power functions.Conclusion The Fieller-type power function and the asymptotic power function can be used to determine sample sizes of crossover trials for bioequivalence assessment of topical ophthalmic drugs.
文摘运用内容分析法对近10年北美体育教学研究的权威学术刊物《Journal of Teaching in Physical Education》刊载的231篇文章的内容特征进行分析,发现:研究主体分布广泛并注重主体间协作,主体专业背景呈多样化;研究主题多热衷于学生性别、学习兴趣与动机、教师专业、职业发展、学习者特定领域学习发展、体育游戏及教师教育评估等方面;研究设计以调查和试验研究为主;研究方法多采用实验法,注重定量研究,属于定性与定量相结合的研究占多数。
