Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable results.Additionally,there is a need to swi...Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable results.Additionally,there is a need to switch from the traditional method validation checklist to provide a high level of assurance of method reliability to measure quality attribute of a drug product.In the present work,evaluation of risk profile,combined standard uncertainty and expanded uncertainty in the analysis of acyclovir were studied.Uncertainty was calculated using cause-effect approach,and to make it more accurately applicable a method was validated in our laboratory as per the ICH guidelines.While assessing the results of validation,the calibration model was justified by the lack of fit and Levene＇s test.Risk profile represents the future applications of this method.In uncertainty the major contribution is due to sample concentration and mass.This work demonstrates the application of theoretical concepts of calibration model tests,relative bias,risk profile and uncertainty in routine methods used for analysis in pharmaceutical field.展开更多
In order to solve the lack of relevant evaluation research on the accuracy of HMP155A humidity sensor calibration results in the past, this paper designs the corresponding experimental scheme, and obtains the correspo...In order to solve the lack of relevant evaluation research on the accuracy of HMP155A humidity sensor calibration results in the past, this paper designs the corresponding experimental scheme, and obtains the corresponding calibration results according to the experimental scheme;Then the measurement uncertainty of the indication error in the calibration results is evaluated by GUM, and the corresponding extended uncertainty </span><i><span style="font-family:Verdana;">U</span></i><sub><span style="font-family:Verdana;">95</span></sub><span style="font-family:Verdana;"> is obtained. Finally, according to the requirements of JJF1094-2016 characteristic evaluation of measuring instruments, combined with the calibration results and the actual situation of </span><i><span style="font-family:Verdana;">U</span></i><sub><span style="font-family:Verdana;">95</span></sub><span style="font-family:Verdana;">, the conformity of the indication error of calibration is determined. The result is that each calibration point of the sensor meets the requirements of conformity determination and is within the qualified range. This research effectively makes up for the blank of the previous research on the conformity determination of the indication error of the calibration results and has strong theoretical and practical significance.展开更多
目前气象计量领域测量不确定度评定一般采用GUM(Guide to the expression of Uncertainty in Measurement,测量不确定度表示指南)方法,该方法存在置信因子近似估计的问题。为进一步提升测量不确定度评定结果的可靠性,提出了一种基于FFT...目前气象计量领域测量不确定度评定一般采用GUM(Guide to the expression of Uncertainty in Measurement,测量不确定度表示指南)方法,该方法存在置信因子近似估计的问题。为进一步提升测量不确定度评定结果的可靠性,提出了一种基于FFT的卷积评定方法。利用FFT算法得到多个不确定度分量的合成分布,并根据指定置信水平准确求出合成分布的置信因子,进而确定扩展不确定度。利用该方法对一款湿度传感器测量不确定度进行了评定,并与GUM方法评定结果进行对比分析。结果表明,该方法计算得到湿度传感器的扩展不确定度为1.54%RH,比GUM方法评定结果(1.68%RH)更加精确,且能直观显示合成分布情况,有助于提高相关业务人员对测量不确定度的理解水平。展开更多
文摘Risk assessment and uncertainty approximation are two major and important parameters that need to be adopted for the development of pharmaceutical process to ensure reliable results.Additionally,there is a need to switch from the traditional method validation checklist to provide a high level of assurance of method reliability to measure quality attribute of a drug product.In the present work,evaluation of risk profile,combined standard uncertainty and expanded uncertainty in the analysis of acyclovir were studied.Uncertainty was calculated using cause-effect approach,and to make it more accurately applicable a method was validated in our laboratory as per the ICH guidelines.While assessing the results of validation,the calibration model was justified by the lack of fit and Levene＇s test.Risk profile represents the future applications of this method.In uncertainty the major contribution is due to sample concentration and mass.This work demonstrates the application of theoretical concepts of calibration model tests,relative bias,risk profile and uncertainty in routine methods used for analysis in pharmaceutical field.
文摘In order to solve the lack of relevant evaluation research on the accuracy of HMP155A humidity sensor calibration results in the past, this paper designs the corresponding experimental scheme, and obtains the corresponding calibration results according to the experimental scheme;Then the measurement uncertainty of the indication error in the calibration results is evaluated by GUM, and the corresponding extended uncertainty </span><i><span style="font-family:Verdana;">U</span></i><sub><span style="font-family:Verdana;">95</span></sub><span style="font-family:Verdana;"> is obtained. Finally, according to the requirements of JJF1094-2016 characteristic evaluation of measuring instruments, combined with the calibration results and the actual situation of </span><i><span style="font-family:Verdana;">U</span></i><sub><span style="font-family:Verdana;">95</span></sub><span style="font-family:Verdana;">, the conformity of the indication error of calibration is determined. The result is that each calibration point of the sensor meets the requirements of conformity determination and is within the qualified range. This research effectively makes up for the blank of the previous research on the conformity determination of the indication error of the calibration results and has strong theoretical and practical significance.
文摘目前气象计量领域测量不确定度评定一般采用GUM(Guide to the expression of Uncertainty in Measurement,测量不确定度表示指南)方法,该方法存在置信因子近似估计的问题。为进一步提升测量不确定度评定结果的可靠性,提出了一种基于FFT的卷积评定方法。利用FFT算法得到多个不确定度分量的合成分布,并根据指定置信水平准确求出合成分布的置信因子,进而确定扩展不确定度。利用该方法对一款湿度传感器测量不确定度进行了评定,并与GUM方法评定结果进行对比分析。结果表明,该方法计算得到湿度传感器的扩展不确定度为1.54%RH,比GUM方法评定结果(1.68%RH)更加精确,且能直观显示合成分布情况,有助于提高相关业务人员对测量不确定度的理解水平。
