In order to apply the knowledge based engineering to solve the low efficiency of serialized design,by analyzing the top-down design characteristics,a composite representation method for the design knowledge is propose...In order to apply the knowledge based engineering to solve the low efficiency of serialized design,by analyzing the top-down design characteristics,a composite representation method for the design knowledge is proposed.The object-knowledge is expressed by framework,and the construction principles of the framework are given,the design knowledge element is used to express the process-knowledge.Then the knowledge reasoning model for design decision-making is established.Finally,a case shows that the proposed method and model are effective.展开更多
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
基金the outsourcing project of the AECC Sichuan Gas Turbine Establishment and the science and technology project of Sichuan province(grant number 2019YFG0312)。
文摘In order to apply the knowledge based engineering to solve the low efficiency of serialized design,by analyzing the top-down design characteristics,a composite representation method for the design knowledge is proposed.The object-knowledge is expressed by framework,and the construction principles of the framework are given,the design knowledge element is used to express the process-knowledge.Then the knowledge reasoning model for design decision-making is established.Finally,a case shows that the proposed method and model are effective.
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.
