Pharmaceutical excipients for topical use may contain impurities, which are often neglected from a toxicity qualification viewpoint. The possible impurities in the most frequently used topical excipients were evaluate...Pharmaceutical excipients for topical use may contain impurities, which are often neglected from a toxicity qualification viewpoint. The possible impurities in the most frequently used topical excipients were evaluated in-silico for their toxicity hazard. Acetol, an impurity likely present in different topical pharmaceutical excipients such as propylene glycol and glycerol, was withheld for the evaluation of its health risk after dermal exposure. 〈br〉 An ex-vivo in-vitro permeation study using human skin in a Franz Diffusion Cell set-up and GC as quantification methodology showed a significant skin penetration with an overall Kp value of 1.82 ？ 10 ？ 3 cm/h. Using these data, limit specifications after application of a dermal pharmaceutical product were estimated. Based on the TTC approach of Cramer class I substances, i.e. 1800 mg/（day？person）, the toxicity-qualified specification limits of acetol in topical excipients were calculated to be 90 mg/mL and 180 mg/mL for propylene glycol and glycerol, respectively.展开更多
评估平均值—极差值质控图(X-Bar and R Charts)在临床检验室内质控中的应用价值。利用SPSS质控程序中的平均值—极差值质控图分析甘油三酯的模拟质控数据,生成X-Bar(平均值)和R(极差值)质控图,并产生多种能力指数和性能指数。平均值—...评估平均值—极差值质控图(X-Bar and R Charts)在临床检验室内质控中的应用价值。利用SPSS质控程序中的平均值—极差值质控图分析甘油三酯的模拟质控数据,生成X-Bar(平均值)和R(极差值)质控图,并产生多种能力指数和性能指数。平均值—极差值质控图正确显示了违反质控规则的质控点,并对此做出了详细的报告;能力指数和性能指数正确反映了质控过程维持在规格限内的能力。平均值—极差值质控图适合于分析临床检验定量项目的质控数据。展开更多
目的:评估单值-移动极差值质控图(Individual and Moving Range Charts)在临床检验室内质控中的应用价值。方法:利用SPSS质控程序分析Bayer120血细胞分析仪的血红蛋白质控数据,生成单值-移动极差值质控图。结果:单值-移动极差值质控图...目的:评估单值-移动极差值质控图(Individual and Moving Range Charts)在临床检验室内质控中的应用价值。方法:利用SPSS质控程序分析Bayer120血细胞分析仪的血红蛋白质控数据,生成单值-移动极差值质控图。结果:单值-移动极差值质控图能准确显示违反质控规则的质控点,并对此做出了详细的报告。结论:单值-移动极差值质控图适合于分析临床检验定量项目的质控数据。展开更多
基金funded by the Institute for the Promotion of Innovation through Science and Technology in Flanders (IWTVlaanderen) to Jente Boonen (091257)the Special Research Fund (BOF) of Ghent University to Lien Taevernier (01D23812)
文摘Pharmaceutical excipients for topical use may contain impurities, which are often neglected from a toxicity qualification viewpoint. The possible impurities in the most frequently used topical excipients were evaluated in-silico for their toxicity hazard. Acetol, an impurity likely present in different topical pharmaceutical excipients such as propylene glycol and glycerol, was withheld for the evaluation of its health risk after dermal exposure. 〈br〉 An ex-vivo in-vitro permeation study using human skin in a Franz Diffusion Cell set-up and GC as quantification methodology showed a significant skin penetration with an overall Kp value of 1.82 ？ 10 ？ 3 cm/h. Using these data, limit specifications after application of a dermal pharmaceutical product were estimated. Based on the TTC approach of Cramer class I substances, i.e. 1800 mg/（day？person）, the toxicity-qualified specification limits of acetol in topical excipients were calculated to be 90 mg/mL and 180 mg/mL for propylene glycol and glycerol, respectively.
文摘评估平均值—极差值质控图(X-Bar and R Charts)在临床检验室内质控中的应用价值。利用SPSS质控程序中的平均值—极差值质控图分析甘油三酯的模拟质控数据,生成X-Bar(平均值)和R(极差值)质控图,并产生多种能力指数和性能指数。平均值—极差值质控图正确显示了违反质控规则的质控点,并对此做出了详细的报告;能力指数和性能指数正确反映了质控过程维持在规格限内的能力。平均值—极差值质控图适合于分析临床检验定量项目的质控数据。
文摘目的:评估单值-移动极差值质控图(Individual and Moving Range Charts)在临床检验室内质控中的应用价值。方法:利用SPSS质控程序分析Bayer120血细胞分析仪的血红蛋白质控数据,生成单值-移动极差值质控图。结果:单值-移动极差值质控图能准确显示违反质控规则的质控点,并对此做出了详细的报告。结论:单值-移动极差值质控图适合于分析临床检验定量项目的质控数据。
