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
The study was designed to explore the potential applications of the real-time cell electronic analysis technology in the quality evaluation of natural medicines. The natural medicinal Flos Carthami was discussed as a ...The study was designed to explore the potential applications of the real-time cell electronic analysis technology in the quality evaluation of natural medicines. The natural medicinal Flos Carthami was discussed as a methodological example and the specific time/dose-dependent cell response profiles （TCRPs） were produced by the real-time cell electronic analysis technology. The similarity and bioactivity were obtained by analyzing all TCRPs. Meanwhile, an HPLC method according to the Chinese Pharmacopeia （edition 2010） was used to evaluate the quality of Flos Carthami. The correlation was obtained by comparing the results produced by the two different approaches. By analyzing the data, five different samples ofFlos Carthami can produce remarkably similar TCRPs. The quality ofFlos Carthami was evaluated by both the HPLC and the TCRPs analysis-based approaches and similar results were obtained. The results suggest that the same natural medicine from different locations could produce similar TCRPs. By analyzing the TCRPs, the bioactivity and quality evaluation of natural medicines can be obtained. This technology is a physiologically relevant approach for the quality evaluation of natural medicines. The ultimate aim of our study is to establish a new standard for quality evaluation.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.
基金financially supported by a Cultivated Project from Nanjing university of Chinese medicine (No. 10XPY01)the National Natural Science Foundation of China (No. 81202922)a Project Funded by the Priority Academic Program Development of Jiangsu Higher Education Institutions, PAPD (No. 2011ZYX3-004)
文摘The study was designed to explore the potential applications of the real-time cell electronic analysis technology in the quality evaluation of natural medicines. The natural medicinal Flos Carthami was discussed as a methodological example and the specific time/dose-dependent cell response profiles （TCRPs） were produced by the real-time cell electronic analysis technology. The similarity and bioactivity were obtained by analyzing all TCRPs. Meanwhile, an HPLC method according to the Chinese Pharmacopeia （edition 2010） was used to evaluate the quality of Flos Carthami. The correlation was obtained by comparing the results produced by the two different approaches. By analyzing the data, five different samples ofFlos Carthami can produce remarkably similar TCRPs. The quality ofFlos Carthami was evaluated by both the HPLC and the TCRPs analysis-based approaches and similar results were obtained. The results suggest that the same natural medicine from different locations could produce similar TCRPs. By analyzing the TCRPs, the bioactivity and quality evaluation of natural medicines can be obtained. This technology is a physiologically relevant approach for the quality evaluation of natural medicines. The ultimate aim of our study is to establish a new standard for quality evaluation.
