Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drug...Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA,EU and China were compared and analyzed.Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs.However,there are still some problems in China’s current post-approval change management systems.According to the model and requirements of the post-approval change management systems of the USA and EU,this paper proposes the following suggestions for the improvement of China’s post-approval change management system.Firstly,electronic files for licensed products should be created.Then,regulatory standards at the national level must be unified.Lastly,the concept of product life cycle management should be implemented.展开更多
The target on the sea surface is complex and difficult to detect due to the interference of backscattered returns from the sea surface illuminated by the radar pulse. Detrended fluctuation analysis(DFA) has been used ...The target on the sea surface is complex and difficult to detect due to the interference of backscattered returns from the sea surface illuminated by the radar pulse. Detrended fluctuation analysis(DFA) has been used successfully to extract the time-domain Hurst exponent of sea-clutter series. Since the frequency of the sea clutter mainly concentrates around Doppler center so that we consider to extract frequency-domain fractal characterization and then detect a weak target within sea clutter by using the difference of frequency-domain fractal characterization. The generalized detrended fluctuation analysis(GDFA) is more flexible than traditional DFA owing to its smoothing action for the clutters. In this paper, we apply the GDFA to evaluate the generalized Hurst exponent of sea-clutter series in the frequency domain. The difference of generalized Hurst exponents between different sea-clutter range bins would be used to determine whether the target exists. Moreover, some simulations with the real IPIX radar data have also been demonstrated in order to support this conclusion.展开更多
Objective In order to investigate the potential mechanisms in troglitazone-induced apoptosis in HT29 cells,the effects of PPARγ and POX-induced ROS were explored.Methods [3-(4,5)-dimethylthiazol-2-yl]-2,5-diphenyltet...Objective In order to investigate the potential mechanisms in troglitazone-induced apoptosis in HT29 cells,the effects of PPARγ and POX-induced ROS were explored.Methods [3-(4,5)-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) assay,Annexin V and PI staining using FACS,plasmid transfection,ROS formation detected by DCFH staining,RNA interference,RT-PCR & RT-QPCR,and Western blotting analyses were employed to investigate the apoptotic effect of troglitazone and the potential role of PPARγ pathway and POX-induced ROS formation in HT29 cells.Results Troglitazone was found to inhibit the growth of HT29 cells by induction of apoptosis.During this process,mitochondria related pathways including ROS formation,POX expression and cytochrome c release increased,which were inhibited by pretreatment with GW9662,a specific antagonist of PPARγ.These results illustrated that POX upregulation and ROS formation in apoptosis induced by troglitazone was modulated in PPARγ-dependent pattern.Furthermore,the inhibition of ROS and apoptosis after POX siRNA used in troglitazone-treated HT29 cells indicated that POX be essential in the ROS formation and PPARγ-dependent apoptosis induced by troglitazone.Conclusion The findings from this study showed that troglitazone-induced apoptosis was mediated by POX-induced ROS formation,at least partly,via PPARγ activation.展开更多
文摘Objective To provide suggestions for further improvement of China’s drug post-approval change management system.Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA,EU and China were compared and analyzed.Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs.However,there are still some problems in China’s current post-approval change management systems.According to the model and requirements of the post-approval change management systems of the USA and EU,this paper proposes the following suggestions for the improvement of China’s post-approval change management system.Firstly,electronic files for licensed products should be created.Then,regulatory standards at the national level must be unified.Lastly,the concept of product life cycle management should be implemented.
基金The National Natural Science Foundation of China Project under contract Nos 41276187 and 41076119the Scientific Research Foundation for Introducing Talents,Nanjing University of Information Science and Technology under contract No.20110310Jiangsu Natural Science Foundation under contract No.BK2011008
文摘The target on the sea surface is complex and difficult to detect due to the interference of backscattered returns from the sea surface illuminated by the radar pulse. Detrended fluctuation analysis(DFA) has been used successfully to extract the time-domain Hurst exponent of sea-clutter series. Since the frequency of the sea clutter mainly concentrates around Doppler center so that we consider to extract frequency-domain fractal characterization and then detect a weak target within sea clutter by using the difference of frequency-domain fractal characterization. The generalized detrended fluctuation analysis(GDFA) is more flexible than traditional DFA owing to its smoothing action for the clutters. In this paper, we apply the GDFA to evaluate the generalized Hurst exponent of sea-clutter series in the frequency domain. The difference of generalized Hurst exponents between different sea-clutter range bins would be used to determine whether the target exists. Moreover, some simulations with the real IPIX radar data have also been demonstrated in order to support this conclusion.
基金supported by the National Basic Research Program (973) of China (No. 2009CB421605, No.2008CB418102)the National Natural Science Foundation of China (No.20890112, No. 21077127)
文摘Objective In order to investigate the potential mechanisms in troglitazone-induced apoptosis in HT29 cells,the effects of PPARγ and POX-induced ROS were explored.Methods [3-(4,5)-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) assay,Annexin V and PI staining using FACS,plasmid transfection,ROS formation detected by DCFH staining,RNA interference,RT-PCR & RT-QPCR,and Western blotting analyses were employed to investigate the apoptotic effect of troglitazone and the potential role of PPARγ pathway and POX-induced ROS formation in HT29 cells.Results Troglitazone was found to inhibit the growth of HT29 cells by induction of apoptosis.During this process,mitochondria related pathways including ROS formation,POX expression and cytochrome c release increased,which were inhibited by pretreatment with GW9662,a specific antagonist of PPARγ.These results illustrated that POX upregulation and ROS formation in apoptosis induced by troglitazone was modulated in PPARγ-dependent pattern.Furthermore,the inhibition of ROS and apoptosis after POX siRNA used in troglitazone-treated HT29 cells indicated that POX be essential in the ROS formation and PPARγ-dependent apoptosis induced by troglitazone.Conclusion The findings from this study showed that troglitazone-induced apoptosis was mediated by POX-induced ROS formation,at least partly,via PPARγ activation.
