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- W2373552593 abstract "Objective: To execute quality control in phase Ⅰ clinical trial by applying Westgard figure of performance and 6 Sigma indexes for finding out problems and promoting quality improvement.Methods: Data of mycophenolate mofetil capsule were collected from our laboratory.The performance Westgard figure for methodological and homochronous quality control were drawn.Ⅰts Sigma values and the QGⅠ were calculated to estimate performance of the methodology and choose control standardization of optimum quality.Results: According to the properties of mycophenolate mofetil,the control standardization for methodological quality was based on 3 points of concentrations in 3 Sigma areas.The control standardization for homochronous quality was based on each batch operation point in 2 Sigma areas.Conclusion: Westgard figure of performance and 6 Sigma indexes can correctly estimate the methodological and homochronous quality control in phase Ⅰ trial,and the optimum quality control standardization can be chosen.The methodology is useful for executing quality control in phase Ⅰ clinical trial." @default.
- W2373552593 created "2016-06-24" @default.
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- W2373552593 date "2011-01-01" @default.
- W2373552593 modified "2023-09-23" @default.
- W2373552593 title "Quality control in phase I clinical trial by applying Westgard figure of performance and six Sigma indexes" @default.
- W2373552593 hasPublicationYear "2011" @default.
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