In this paper, we report the results of quality control based in pbysicochemical characteriza- tion and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were ...In this paper, we report the results of quality control based in pbysicochemical characteriza- tion and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph II1, sample B consisted in pure polymorph I1, sample C consisted in a mixture of fluconazole Form Ili, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific展开更多
Quality assessment is a critical component incrowdsourcing-based software engineering(CBSE)as soft-ware products arc developed by the crowd with unknownor varied skills and motivations.In this paper.we proposea novel ...Quality assessment is a critical component incrowdsourcing-based software engineering(CBSE)as soft-ware products arc developed by the crowd with unknownor varied skills and motivations.In this paper.we proposea novel metric called the project score to measure the perfor-mance of projects and the quality of products for compctition-based software crowdsourcing devclopment(CBSCD)activ-ities.To the best of our knowledge,this is the first work to deal with the quality issue of CBSE in the perspective ofprojccts instead of contcsts.In particular,we develop a hi-crarchical quality evaluation framework for CBSCD projects and come up with two metric aggregatibn modcls for projectscores.The first model is a modified squale model that canlocate the sofiware modules of poor quality,and the secondone is a clustering-based aggregation model,which takes dif-ferent impacts of phases into account.To test the effective-ness of the proposed metrics.we conduct an empirical studyon TopCoder,which is a famous CBSCD platform.Resultsshow that the proposed project score is a strong indicator ofthe performance and product quality of CBSCD projects.wealso find that the clustering-based aggregation model outpcr-forms the Squale one by increasing the percentage of the per-formance evaluation criterion of aggregation models by anadditional 29%.Our approach to quality assessment for CB-sCD projects could potentially facilitate software managersto assess the overall quality of a crowdsourced project con-sisting of programming contests.展开更多
文摘In this paper, we report the results of quality control based in pbysicochemical characteriza- tion and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph II1, sample B consisted in pure polymorph I1, sample C consisted in a mixture of fluconazole Form Ili, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific
基金supported by grants from State KeyLaboratory of Software Development Environment of BUAA of China(SKLSDE-2018ZX-03)NSFC(Grant No.61532004).
文摘Quality assessment is a critical component incrowdsourcing-based software engineering(CBSE)as soft-ware products arc developed by the crowd with unknownor varied skills and motivations.In this paper.we proposea novel metric called the project score to measure the perfor-mance of projects and the quality of products for compctition-based software crowdsourcing devclopment(CBSCD)activ-ities.To the best of our knowledge,this is the first work to deal with the quality issue of CBSE in the perspective ofprojccts instead of contcsts.In particular,we develop a hi-crarchical quality evaluation framework for CBSCD projects and come up with two metric aggregatibn modcls for projectscores.The first model is a modified squale model that canlocate the sofiware modules of poor quality,and the secondone is a clustering-based aggregation model,which takes dif-ferent impacts of phases into account.To test the effective-ness of the proposed metrics.we conduct an empirical studyon TopCoder,which is a famous CBSCD platform.Resultsshow that the proposed project score is a strong indicator ofthe performance and product quality of CBSCD projects.wealso find that the clustering-based aggregation model outpcr-forms the Squale one by increasing the percentage of the per-formance evaluation criterion of aggregation models by anadditional 29%.Our approach to quality assessment for CB-sCD projects could potentially facilitate software managersto assess the overall quality of a crowdsourced project con-sisting of programming contests.