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
English has not only become the international language, as it is spoken by a large number of native speakers of other languages and severs as a language of wider communication, but also has achieved a genuinely global...English has not only become the international language, as it is spoken by a large number of native speakers of other languages and severs as a language of wider communication, but also has achieved a genuinely global status. Thus the spread of English provides language teachers with an abundance of data for relating second language issues to pedagogical concerns. To achieve positive pedagogical goals, it is very essential for language teachers to be aware of the status and functions of Englishes in the world today and in the future as well. To serve the purpose, this article suggests that varieties of English should be taught and special attention should be paid to teaching culture in our College English classroom so as to help our students to establish a sphere of interculturalism.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English has not only become the international language, as it is spoken by a large number of native speakers of other languages and severs as a language of wider communication, but also has achieved a genuinely global status. Thus the spread of English provides language teachers with an abundance of data for relating second language issues to pedagogical concerns. To achieve positive pedagogical goals, it is very essential for language teachers to be aware of the status and functions of Englishes in the world today and in the future as well. To serve the purpose, this article suggests that varieties of English should be taught and special attention should be paid to teaching culture in our College English classroom so as to help our students to establish a sphere of interculturalism.
