FDA clearly provides the rules for drug submission and requires that all the studies which are suitable in electronic format should follow CDISC standard.Due to the detailed contents of submission package,it's always a big challenge to submission institution and staff.It usually costs a lot of time for company or member to complete the validation before submission to FDA.Based on the ADaM submission package,this paper gives a clear picture of validation checkpoint checklist.For every checkpoint,it will see and find the ways to automatically validate through SAS macros or tools.So that it will decrease the manual checking workload,saving the time and shorten the submission period.

Pb exhibits toxic effects on various organ and tissues.Despite the prohibition of leaded gasoline and paint,a considerable amount of Pb remains in the environment,posing a significant threat to public health and safety.Therefore,it is urgent to clarify the mechanisms of Pb toxicity.Numerous studies have indicated that mitochondria are the sensitive targets of Pb.Pb can not only induce mitochondrial oxidative stress and energy metabolism disorder,but also cause mitochondrial dysfunction,leading to inflammation,apoptosis,autophagy,and other disorders.Therefore,mitochondrial dysfunction is a critical mechanism of Pb toxicity.This article reviews the research progress in the effects of Pb on mitochondrial membrane permeability,mitochondrial autophagy,mitochondrial fusion and fission,aiming to provide a reference for future mechanism studies and intervention treatment of Pb poisoning.

This paper evaluates the impact of basic medical insurance on the health status of flexible employees based on the CFPS three-period balanced panel data from 2016 to 2020,using Ordered Probit Model and Two-way Fixed Effects Model.It is found that basic medical insurance significantly promotes the physical and mental health of flexible employees.Further heterogeneity analysis reveals that the health performance of basic medical insurance was particularly significant for middle-aged and old-aged,rural,east-central and better-educated flexible employees.In addition,the mediation effect analysis indicates that basic medical insurance promots the health of flexible employees through the mediation channels of improving the utilization of medical services and reducing the burden of disease costs.This paper suggests promoting the comprehensive participation of flexible employees;improving the medical insurance system for middle-aged and elderly flexible employees;accelerating the sinking of high-quality medical resources to rural and western areas;and actively exploring a new mode of participation in medical check-ups by flexible employees,with a view to lowering the incidence of serious illnesses and major illnesses among flexible employees and improving health performance.

Objective To establish an experimental model of acute cerebral schistosomiasis japonica and explore the MRI manifestations of acute cerebral schistosomiasis. Methods Rabbits were divided into 3 groups with 10 rabbits in each group. The rabbits in the experimental group were directly injected with suspension fluid of Schistosoma japonicum eggs(0.9 mg,1 ml) by the cranial drilling method,those in the negative control group were given saline(1 ml)by the same method above-men-tioned,and those in the blank control group were not given any treatment. Antibiotic was given to the first two groups after the op-eration. The clinical manifestations of the 3 groups were observed,and the magnetic resonance imaging(MRI)was performed in 30 days post-operation,and then the brain tissues were taken for pathological examinations. Results All the rabbits in the ex-perimental group exhibited inappetence,various neurological symptoms including hemiplegia,and weight loss after the opera-tion;while those in the negative control group showed inappetence in 3 days after the operation,and 1 week later,the symptom disappeared;there were no adverse reactions in the blank control group. MRI of the experimental group showed nodular or patchy enhancement on T1WI enhancement,brain edema,abnormal ventricular dilatation,and needle augmentation. SWI dis-played hypointense in the abnormal enhanced nodules and flaky hypointense on the operation brain. In the negative control group,2 rabbits showed abnormal enhancement of the needle canal,and 1 showed mild dilatation of the ventricle. The blank control group showed normal manifestations. The pathological examinations showed abnormal appearances in 10 rabbits of the ex-perimental group,including 6 with S. japonicum egg granuloma nodules,nonspecific granuloma nodules coexisted with perivas-cular inflammation;no granuloma nodules were found in the negative control group,but 2 rabbits showed vascular inflamma-tion;the blank control group showed the normal brain tissue. Conclusions An experimental model of acute cerebral schistoso-miasis is successfully established in rabbits by intracranial injection of schistosome eggs. The MRI examination combined with the clinical manifestations can improve the accuracy of early diagnosis of cerebral schistosomiasis.

Statistical P value and its threshold have been controversial worldwide for a while. Recent heated debate was triggered by two practical issues: unexplainable high false positive rate in biomedical research, and global misunderstood of "statistical significance" in scientific community. Thus, part of scientists suggests applying more stringent significance level (from 0.05 to 0.005), or even giving up the use of significance level. We believe that they are throwing the baby out with the bath water. These suggestions will not contribute to any improvement of this unfavorable situation but will lead the scientific decision?making to a more difficult and subjective corner. Scientists should use statistical P value and threshold only if they correctly understand the soul of statistics?uncertainty. Statistical significance is neither sole nor dominant criterion to measure the scientific value, but an honest assistant. Scientific decision?making should initiate from the scientific experimental design, followed by rigorous implementation and transparent analysis, and synthesize a variety of information to reach a tenable conclusion.

Statistical P value and its threshold have been controversial worldwide for a while. Recent heated debate was triggered by two practical issues: unexplainable high false positive rate in biomedical research, and global misunderstood of "statistical significance" in scientific community. Thus, part of scientists suggests applying more stringent significance level (from 0.05 to 0.005), or even giving up the use of significance level. We believe that they are throwing the baby out with the bath water. These suggestions will not contribute to any improvement of this unfavorable situation but will lead the scientific decision?making to a more difficult and subjective corner. Scientists should use statistical P value and threshold only if they correctly understand the soul of statistics?uncertainty. Statistical significance is neither sole nor dominant criterion to measure the scientific value, but an honest assistant. Scientific decision?making should initiate from the scientific experimental design, followed by rigorous implementation and transparent analysis, and synthesize a variety of information to reach a tenable conclusion.

Objective:To analyze the surveillance results of iodine deficiency disorders in Fuzhou City, Jiangxi Province, so as to master the iodine nutrition level of key population and evaluate the prevention and treatment effect of iodine deficiency disorders in the city.Methods:From 2017 to 2019, counties (districts) under the jurisdiction of Fuzhou City in Jiangxi Province were divided into five sampling areas (east, west, south, north, and central). A township was selected in each area, and a primary school was selected in each township. Forty children aged 8 to 10 were elected in each primary school. At the same time, 20 pregnant women were selected from each area. Home salt samples and urine samples of children and pregnant women were collected to determine the contents of salt iodine and urinary iodine, and the thyroid of children was examined by B-mode ultrasonography.Results:A total of 6 001 salt samples from children's homes were tested. The median iodine content of children's home salt samples was 24.60 mg/kg, the coverage rate of iodized salt reached 99.77% (5 987/6 001), and the edible rate of qualified iodized salt was 96.20% (5 773/6 001). A total of 3 000 salt samples from pregnant women's homes were tested. The median iodine content of pregnant women's home salt samples was 24.81 mg/kg, the coverage rate of iodized salt reached 99.97% (2 999/3 000), and the edible rate of qualified iodized salt was 96.97% (2 909/3 000). A total of 6 001 children's urine samples were tested, and the median urinary iodine was 172.23 μg/L. A total of 3 000 pregnant women's urine samples were tested, and the median urinary iodine was 178.35 μg/L. The rate of goiter in children was 1.00% (8/800) in 2017, 1.33% (8/600) in 2018, and 1.12% (9/800) in 2019.Conclusion:The iodine nutrition level of children and pregnant women in Fuzhou City of Jiangxi Province is suitable and meets the requirements of iodine deficiency disorders elimination standard.

Objective To analyze the scores of National Institutes of Health stroke scale(NIHSS),geriatric nutritional risk index(GNRI),motor function in dependence measure(MFIM)and the risk of stroke-related pneumonia(SAP).Methods Patients with stroke admitted from November,2021 to May,2022 were included.The scores of NIHSS,GNRI and MFIM at admission were collected,and they were divided into non-SAP group(n=232)and SAP group(n=86)according to whether pneumonia occurred within one week after stroke.According to the receiver operating characteristic(ROC)curve,the predictive ability of each score to SAP was evaluated,and each score was grouped according to the best cut-off point.logistic regression model and restricted cubic spline were used to analyze the relationship between each score and SAP.Results A total of 318 stroke patients were enrolled in the study including 86 in SAP group and 232 in non-SAP group.Logistic regression shows that,levels of NIHSS score(OR=32.783,95％CI:16.366～65.671,P<0.001),MFIM score(OR=0.052,95％CI:0.027～0.100,P<0.001)and GNRI score(OR=0.262,95％CI:0.144～0.476,P<0.001)were associated with SAP.Restricted cubic spline analysis shows that,there was a nonlinear dose-response relationship between SAP risk and NIHSS score(P-general trend<0.001,P-nonlinear=0.002),GNRI score(P-general trend<0.001,P-nonlinear<0.001).Conclusion NIHSS,MFIM,and GNRI scores are associated with the risk of SAP in stroke patients,and some of them have nonlinear relationships.

Objective:To investigate epidemic status of avian influenza virus (AIV) in live poultry market (LPM) and evaluate its potential public health threat and develop control measures in Nanchang city.Methods:Forty-seven LPM in 10 counties/districts of Nanchang city were selected as surveillance sites by using cluster random sampling. Poultry swabs and environmental samples were obtained from LPM. Real time RT-PCR was used for AIV typing and subtyping. Excel 2016, SPSS 24.0 and Prism Version 7 (GraphPad) software were used for statistical analysis.Results:Total of 9 248 poultry swabs and environmental samples were collected. 1 525 specimens(16.49%) were positive for AIV. H7 and H9 were the dominant subtypes, and H9 positive rate was highest (17.44%). Sewage (21.46%) and throat swabs (20.46%) had higher positive rates than the other types of samples. Chicken and duck were dominant hosts for AIV, the corresponding positive rates were 22.80% and 13.95%. The positive rates of Honggutan district, Anyi county and Xinjian district were 25.52%, 24.31% and 22.35%, which were higher than that of the other counties/districts. Each county/district had its unique subtype composition of AIV.Conclusions:The coexistence of H7, H9 and other subtypes of AIV in LMP was identified in Nanchang city. Continuing active surveillance and comprehensive control measures should be taken to reduce the potential risk of human infection.

Objective To study on the application value of flipped classroom and PBL in the teaching process of sanitary chemistry experiment. Methods 112 students studied in School of Public Health in Nanchang University were considered as research subjects, including Preventive Medicine grade 2014 class 1 (observation group, n=57) and class 2 (control group, n=55). The students were taught with flipped classroom model in the control group , while flipped classroom combined with PBL was applied in the observation group. The learning effect of the two groups was evaluated by using the form of "Richter score scale"in the self-made form. The data was input using Epidata 3.0 and processed by SPSS 18.0, and it was analyzed by t test and 2 test. Results The evaluation index scores (learning attitude, ability improvement, learning cooperation, professional quality improvement) in the observation group were significantly higher than that of thecontrol group (P<0.05). Besides, the final test scores were also significantly higher in the observation group than those in control group [(83.56 ±10.81) vs. (69.37 ±10.45), t=7.059, P=0.000]. Conclusion Combining flipped classroom with PBL in the teaching process of sanitary chemistry experiment for the students majored in Preventive Medicine not only improves students' exam results, but also helps students improve their learning attitude, learning ability, professional quality and so on. Therefore, the teaching method is worthy of wider application.