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Human bioequivalence testing is an important part of evaluating the quality of a formulation. Although these drugs have a large amount of safety data and clinical application data, they may still have ethical risks in healthy subjects. The definition of healthy volunteers, the general inclusion and exclusion criteria, auxiliary inclusion and exclusion criteria, and inclusion and exclusion criteria considering drug specificity are summarized. The basis for determining whether abnormal test values are clinically significant when screening healthy subjects and the considerations for improving the screening pass rate are discussed. It is expected to provide useful reference for the smooth implementation of human bioequivalence testing.
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Objective To investigate the time efficiency and accuracy of atlas-based auto-segmentation ( ABAS ) software with different atlas template numbers and layers of computed tomography ( CT ) scans in delineation of the target tissues of cervical cancer patients receiving radiotherapy . Methods The CT images from 20, 40, 60, 80, 100, and 120 patients with cervical cancer were separately selected as atlas templates for MIM auto-segmentation software, and the CT-based tumor volumes of another 20 patients with cervical cancer were manually contoured by physicians. The quality of contours obtained automatically from the software and manual contouring was compared by one-way analysis of variance ( ANOVA ) , randomized block ANOVA, and least significant difference t test. The impact of atlas template numbers and layers of CT scans on the accuracy and time efficiency of MIM software was analyzed based on the time spent in delineation, dice similarity coefficient, and overlap index. Results Taking manual contouring as the reference, no significant differences were observed in the accuracy and time efficiency of auto-contouring when atlas template numbers ranged from 20 to 120(all P>005). The ABAS auto-contouring significantly shortened the time for target contours when the layers of CT scans were less than 65 ( all P>005 ) , but reduced the accuracy of rectal contours (P=0000), while CT scans with 67 layers achieved the highest accuracy of rectal contours ( P= 0037 ) . Conclusions The ABAS software shows an advantage in delineation of the target tissues of cervical cancer patients receiving radiotherapy, and 20 templates are suggested to construct this atlas. The CT scans with 65 layers are recommended for patients when target tissues include the bladder, femur, and spinal cord, and CT scans with 67 layers are recommended for patients when target tissues include the rectum.
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Objective To investigate the time efficiency and accuracy of atlas-based auto-segmentation ( ABAS ) software with different atlas template numbers and layers of computed tomography ( CT ) scans in delineation of the target tissues of cervical cancer patients receiving radiotherapy . Methods The CT images from 20, 40, 60, 80, 100, and 120 patients with cervical cancer were separately selected as atlas templates for MIM auto-segmentation software, and the CT-based tumor volumes of another 20 patients with cervical cancer were manually contoured by physicians. The quality of contours obtained automatically from the software and manual contouring was compared by one-way analysis of variance ( ANOVA ) , randomized block ANOVA, and least significant difference t test. The impact of atlas template numbers and layers of CT scans on the accuracy and time efficiency of MIM software was analyzed based on the time spent in delineation, dice similarity coefficient, and overlap index. Results Taking manual contouring as the reference, no significant differences were observed in the accuracy and time efficiency of auto-contouring when atlas template numbers ranged from 20 to 120(all P>005). The ABAS auto-contouring significantly shortened the time for target contours when the layers of CT scans were less than 65 ( all P>005 ) , but reduced the accuracy of rectal contours (P=0000), while CT scans with 67 layers achieved the highest accuracy of rectal contours ( P= 0037 ) . Conclusions The ABAS software shows an advantage in delineation of the target tissues of cervical cancer patients receiving radiotherapy, and 20 templates are suggested to construct this atlas. The CT scans with 65 layers are recommended for patients when target tissues include the bladder, femur, and spinal cord, and CT scans with 67 layers are recommended for patients when target tissues include the rectum.
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Objective To establish nude mouse model with human brain glioma SHG-44 and understand its growing characteristics in vivo.Methods The 4-week-old male mice were randomly divided into high density cell suspension inoculation group(n=10),low density cell suspension group(n=10),the tumor tissue mass vaccination group(n=10)and the blank control group with normal saline injection(n=10).The SHG-44 human brain glioma cell suspension was injected into the subcutaneous of the nude mice' s armpit.The tumor tissue was cut into 1 mm3 after tumor tissue growth and formation,and re-inoculated into the subcutaneous of the new nude mice' s armpits.Apart from daily observation,the long and short diameters of tumor were recorded every 5 days after graft.All the mice were sacrificed at 60 days and the tumor tissues were harvested for pathological examination.Results With a longer incubation period and slower growth rate,the tumor formation rate in high density cell suspension inoculation group and low density cell suspension group was lower compared with that in the tumor tissue mass vaccination group.Around day 20,grafted tumor appeared remarkably big((41.51 ±6.42)mm3) with good morphology.On day 50,the tumor derived from group the tumor tissue mass vaccination group((565.69± 123.36)mm3) showed a bigger size in comparison with that from high density cell suspension inoculation group((203.85±104.63) mm3) and low density cell suspension group ((153.02± 31.76) mm3,all P＜0.05).The tumors in three groups were well defined with a rich vascularity and no apparent invasion was observed.The positive expression of GFAP and S-100 in a large body of tumor cells was observed under optical microscope.Conclusion With a shorter incubation period and faster growth,the mouse tumor models established with tissue pieces from the tumor-bearing mice are much better compared to those with cell suspension.
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Bronchopulmonary dysplasia(BPD) is a chronic lung disease of prematurity mainly affecting preterm infants with low birth weights, especially those treated with mechanical ventilation and oxygen therapy.There is no specific treatment for BPD until now.Administration of mesenchymal stem cells seems to be an promising novel treatment.Mesenchymal stem cell(MSC) can attenuate lung injury in an amount of animal experiments.But the mechanism is unclear yet.The best dose, timing and the application route of transplantation as the standard treatment strategy is still unresolved.The phase Ⅰ clinical trail shows short-term safety and efficacy of MSC administration.Phase Ⅱ trails and long-term safety studies are under way.This review focuses on the recent achievement in treating BPD with MSC transplantation.