Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.
China ; Data Collection ; standards ; Documentation ; standards ; Information Storage and Retrieval ; methods ; standards

T were also detected in the controls.Conclusion Nephrotic syndrome may be associated with NPHS2 identified in children.

Characteristics and measurement principles of reference methods in clinical biochemistry were described.Implementation of reference systems is one of the most effective approaches to improve the accuracy and comparability of clinical laboratory test results.Reference methods are the key components of reference systems.Reference methods should have measurement uncertainties that meet the requirements of the intended use,and thus should be based on reliable measurement principles.For the well-defined biochemistry analytes,reference methods have been almost all based on instrumental analysis.Isotope dilution mass spectrometry (ID/MS) is considered most reliable and has been the major analytical principle of the reference methods.ID/MS analysis is accurate but expensive.Use of other validated instrumental analyses as reference measurement principles would be justified.

Ultrasound contrast agent microbubbles combined with low frequency ultrasound named as low-frequency ultrasound-targeted microbubble destruction technology has become an effective and non-invasive anti-tumor therapy for deep tumors.It can enhance the efficacies of chemotherapy,gene therapy,immunotherapy,and anti-angiogenic therapy by improving cell membrane permeability and destroying tumor neovasculature.It can be applied to sonodynamic therapy and realize multimodal synergistic therapy on the basis of nanoparticles,which increases the anti-tumor efficiency and offers a promising target therapy for tumors.
Contrast Media ; Genetic Therapy ; Humans ; Microbubbles ; Neoplasms ; Ultrasonography

0.05).Setting the threshold of MOV at 6.4 cm~3 offered the best compromise between sensitivity (84.8%)and specificity(87.5%),and setting the threshold of MaxOV at 8.6 cm~3 offered the best compromise between sensitivity(75.8%)and specificity(95.2%)and setting the threshold of MFN at 8 offered the best compromise between sensitivity(86.7%)and specificity(78.3%).Conclusions Ovarian morphology by ultrasonography yields satisfactory diagnostic accuracy for adolescent PCOS.Taking MOV≥ 6.4 cm~3 or MaxOV≥8.6 cm~3 or MFN≥8 as an ultraphonic criterion for pubertal PCOS offer the best compromise between sensitivity and specificity.

Apoptosis ; drug effects ; Cell Division ; drug effects ; Esophageal Neoplasms ; pathology ; Humans ; Selenomethionine ; pharmacology ; Tumor Cells, Cultured

To study the relation between drug release and the drug status within curcumin-loaded microsphere, SPG (shirasu porous glass) membrane emulsification was used to prepare the curcumin-PLGA (polylactic-co-glycolic acid) microspheres with three levels of drug loading respectively, and the in vitro release was studied with high-performance liquid chromatography (HPLC). The morphology of microspheres was observed with scanning electron microscopy (SEM), and the drug status was studied with X-ray diffraction (XRD), differential scanning calorimetry (DSC) and infrared analysis (IR). The drug loading of microspheres was (5.85 ± 0.21)%, (11.71 ± 0.39)%, (15.41 ± 0.40)%, respectively. No chemical connection was found between curcumin and PLGA. According to the results of XRD, curcumin dispersed in PLGA as amorphous form within the microspheres of the lowest drug loading, while (2.12 ± 0.64)% and (5.66 ± 0.07)% curcumin crystals was detected in the other two kinds of microspheres, respectively, indicating that the drug status was different within three kinds of microspheres. In the data analysis, we found that PLGA had a limited capacity of dissolving curcumin. When the drug loading exceeded the limit, the excess curcumin would exist in the form of crystals in microspheres independently. Meanwhile, this factor contributes to the difference in drug release behavior of the three groups of microspheres.
Calorimetry, Differential Scanning ; Curcumin ; chemistry ; Drug Liberation ; Lactic Acid ; Microscopy, Electron, Scanning ; Microspheres ; Polyglycolic Acid ; X-Ray Diffraction

To investigate the effect of compound Chinese traditional medicine PC-SPES II I in inhibiting proliferation of human prostate cancer cell LNCaP based on the androgen receptor (AR) signaling pathway. The effect of PC-SPES II on LNCaP cell proliferation was detected by MTT assay. According to the findings, at the mass concentration of 180-1 440 mg x L(-1), PC-SPES II significantly inhibited the proliferation of LNCaP cells; the IC50 of PC-SPES II at 24 h and 48 h were 311.48, 199.01 mg x L(-1), respectively. The flow Cytometry detection showed 240 mg x L(-1) PC-SPES II arrested cells in G2/M phase, and an obvious apoptotic peak appeared before G0/G1 peak and rose over time. Meanwhile, Hoechst 33258 staining revealed apoptotic cellular morphology. Annexin V-FITC/PI staining manifested an increase in apoptotic cell ratio at the PC-SPES II concentration of 480 mg x L(-1) in a dose dependent manner. The prostate specific antigen (PSA) secretion of LNCaP cells was tested by PSA ELISA kit. Besides, compared with 25 mg x L(-1) Bic, 480 mg x L(-1) PC-SPES II significantly reduced the cell secretion of PSA. The AR and PSA mRNA and protein expressions were detected by qRT-PCR and Western blot. According to the results, after the induction of LNCaP cells with synthetic androgen 25 μg x L(-1) R1881, 240-480 mg x L(-1) PC-SPES II notably down-regulated the AR and PSA mRNA and protein expressions and inhibited the translocation of AR from cytoplasm to nucleus. In summary, PC-SPES II significantly can inhibit the in vitro proliferation of LNCaP cells and arrest cell cycle arrest in G2/M phase. Its mechanism may be associated with the down-regulation of the AR and PSA expressions and the inhibition of AR nuclear translocation.
Antineoplastic Agents, Phytogenic ; pharmacology ; Cell Line, Tumor ; Cell Proliferation ; drug effects ; Drugs, Chinese Herbal ; pharmacology ; Humans ; Male ; Prostate-Specific Antigen ; genetics ; metabolism ; Prostatic Neoplasms ; drug therapy ; genetics ; metabolism ; physiopathology ; Receptors, Androgen ; genetics ; metabolism ; Signal Transduction ; drug effects

Objective To design and implement an automatic analysis and evaluation system for the image parameters of medical MRI quality testing.Methods The system was developed and debugged by the study on MRI image quality parameters,the image denoising,integration,extraction and etc by MATLAB processing platform as well as the comparison and comparative calculation of the obtained data.Results The system replaced manual operation by auto processing and parameters analysis of MRI quality inspection image.Conclusion The system enhances the efficiency and avoids artificial error,and has a promising prospect in the future.

Objective To investigate the dose- and time-effects of astragaloside Ⅳ(XGA) on collagen of myocardial fibroblasts in rats.Methods The myocardial fibroblasts of rats were separated by collagenase and trypsinase digestive method,and the cell culture system was established. After XGA in different concentrations and at different time points was administered in fibroblast culture systems,the mRNA expression levels of collagen,matrix metalloproteinases(MMP)-1,-2,-9,tissue inhibitor of metalloproteinase(TIMP)-1 and -2 were measured with reverse transcription-polymerase chain reaction(RT-PCR) test.Results After XGA administration with different doses and at different time points was adminstered,the gel electrophoresis product of RT-PCR in fibroblast culture system expressed the mRNA of type Ⅰ,Ⅲ and Ⅳ collagens,MMP-1,-2,-9,TIMP-1 and -2;but the mRNA expression levels of type Ⅰ,Ⅲ and Ⅳ collagens,TIMP-1 and -2 decreased and the mRNA expression levels of MMP-1,-2,and -9 increased compared to those before XGA administration;the mRNA expression of type Ⅰ,Ⅲ and Ⅳ collagens,MMP-1,-2,-9,TIMP-1 and -2 decreased or increased gradually with the increase of doses and the prolonged time of XGA use.The mRNA expression levels of type Ⅰ,Ⅲ and Ⅳ collagens,TIMP-1 and -2 were negatively related to the doses and action times of XGA(r=-0.927 to -0.637 P= 0 to 0.024);and the mRNA expression levels of MMP-1,-2 and -9 were positively related to the doses and action times of XGA(r=0.672 to 0.962 P=0 to 0.034).Conclusion XGA can markedly reduce the collagen formation of myocardial fibroblasts in rats,and its mechanisms are related to the inhibiting of collagen synthesis and the increase of collagen degradation.