Objective To develop the pathway of vancomycin dosage decision based on therapeutic drug monitoring (TDM) in order to improve the clinic operability.Methods To systematically study the TDM target of vancomycin and their variances among populations,infusion approach and decided factors of dosing.Results It was found that area under curve/minimum inhibitory concentration (AUC/MIC) was a more accurate target compared to trough concentration for vancomycin.The trough concentration of 10-15 mg · L-1 may not be enough.The pathway of vancomycin dosage decision had been developed based on patients' characteristics.The simple calculation approach was relative inaccurate but simple and efficiency.The pharmacokinitc/pharmacodynamic (PK/PD) modeling approach was more accurate but relative complex and needing supportive software.The special parameters need to be considered for special populations.Conclusion The pathway of vancemycin dosage decision based on TDM have been developed and it can be used to improve the clinic operability and provide clear decision path for clinics.

Taking Children's Hospital in Hunan Province as an example,the paper introduces the design and application of the security mode for the mobile business platform of hospital from the aspects of the overall structure,implementation plans of security access equipment,security authentication modes and strategies,etc.,and provides ideas for safely implementing remote deployment and mobile application.

In order to improve the access and control of core data in medical information security,the paper builds a virtual isolation private cloud storage architecture in hospital,including virtualized reconstruction,metadata model application based on hierarchical model,access to remote clients design and application based on virtual isolation and so on,providing a reliable method for the isolation and intercommunication between the intranet and extranet.

Rapid screening and characterization of bioactive compounds from traditional Chinese medicines ( TCM) is one of the highlighted re-search challenges in the field of drug development.Target molecule affin-ity coupled with mass spectrometry ( MS) has become a new method for the screening of bioactive compounds from complex mixture, the recent development of which since 2005 will be reviewed.According to the prin-ciple of affinity screening, the methods could be classified into pre -column affinity screening including ultrafiltration -MS, size -exclusion chromatography-MS, turbulent-flow chromatography-MS, restricted-access material-MS and immobilized target-MS and post-column af-finity screening (HPLC-continuous-flow bioassay-MS).Each meth-od with its typical applications would be introduced, providing technique references for the screening of bioactive compounds from complex mixture such as TCM.

Objective To develop a HPLC method for simultaneous de-termination of six coumarins in Radix Glehniae from different sources. Methods The samples were analyzed by HPLC after pressurized liquid extraction ( PLE ) .The chromatographic conditions were as following:The column was Kinetex core-shell-C18 column (50 mm ×4.6 mm, 2.6 μm) , the mobile phase consisted of acetonitrile-water using gradi-ent elution, the flow rate was 0.4 mL? min-1 and the column tempera-ture was 30℃.The detection wavelength was set at 310 nm and the sam-ple injection volume was 20 μL.The method was validated by investiga-ting its specificity, linearities and limit of detection, precision, extraction recovery, stability and repeatability.Results Six components were de-termined by HPLC, including psoralen, xanthotoxin, bergapten, impera-torin, cnidilin and isoimperatorin. The linearities of them were good ( r≥0.999 2 ) in the concentration ranges of 0.50 -10.00 , 1.00-20.00, 0.32-6.40, 0.25 -5.00, 0.05 -1.00, 0.17 -3.50μg? mL-1 , respectively.The coumarins showed the overall recoveries ranging from 91.7%-107.6%.The contents of six compounds of Radix Glehniae from different areas had an obvious difference.Conclusion Six coumarins in Radix Glehniae were analyzed by PLE and HPLC. The method has good specificity, reproducibility and high sensitivity, which can be applied for the quality control of Radix Glehniae.

The pediatric population is different from adults in their physi-ological function and tissues structure, and therefore they should not be assumed simply as the small adults.The drug development for pediatric population is helpful to improve the health of children in the whole coun-try.However, the clinical investigation of medicinal products for adults can not apply for children and there has not available guidance for chil-dren for a while.Accordingly, Chinese Food and Drug Administration ( CFDA) issues the guidance for clinical investigation of medicinal prod-ucts in the pediatric population, which ensure the clinical trials are more scientific and ethic. This paper means to interpret the guidance and therefore to help the development of clinical trials in pediatric population.

The pediatric population is different from adults in their dis-ease types and medication use in clinics.The drug clinic trial in pediatric population provides reliable clinic data for new drug development and medication use, and is helpful to promote the health of children.Howev-er, considering the specificity of children, it is changeable to conduct the drug clinic trials, especially for the study protocol design.Accordingly, CFDA issues the guidance for clinical investigation of medicinal products in the pediatric population, which ensure the clinical trials are more sci-entific and ethic.This paper means to interpret the guidance and there-fore to help the development of clinical trials in pediatric population.

Objective To understand the domestic situation of the clinical research coordinator ( CRC) training, and discuss the standard training of CRCs.Methods Adopt the method of questionnaire , using descriptive statistics and inferential statistics method , analysis and sum-marize the problems existing in the CRC training.Results The trainings in different companies are diverse , and the training content is too simple.Conclusion China ’ s CRC industry need the standard training , we should study the experience of Japan and the United States , and establish China ’ s own CRC training system and evaluation system.

During the screening process,the women at childbearing age have to take the pregnancy test in order to avoid the harm of some new drugs for fetal or neonatal.However in the clinical process,some researchers have doubts,for example,if it is necessary for all the childbearing subjects to take a pregnancy test while some subjects do not or have no chance to get pregnant.Whether the regular urine pregnancy test that cannot indeed trace the source could reach the requirements of drug clinical trials'verification? In most clinical protocols,there is such a brief description like pregnancy or lactation women,is it rigid? Therefore,we put forward our own opinion and suggestion after investigating relevant laws,regulation and literature and combining the pregnancy description of 92 drugs clinical trial protocols.We suggest that the childbearing age women who do not or have no chance to get pregnant by asking the medical history do not take the pregnancy test.In the exclusion standard we should describe all the situation of pregnant in detail including the requirement and limitation for mail.What's more,it is also important to strengthen the education of the subjects and pay special attention on the subjects who will get pregnant in a short period for protecting their right and finishing the experiment.

Objective Perform pharmacokinetic data management,calculation and statistics to meet the current regulatory requirements for good practice,consistence and integrity of the data.Methods A method with flow diagrams was proposed and used for the pharmacokinetic data management and statistics.It mainly includes:data and their format,data receiving and checking,data lock,pharmacokinetic calculation and statistics,results reviewing and locking,reporting and archiving.Results Experiences from real world cases indicated data management with flow diagrams could accurately record the time events for every task,guarantee the accuracy of each calculation,and minimize errors.Conclusion The proposed method has the advantages of easy tracking,consistence,high efficiency and easy re-calculation etc,and could meet the current regulatory requirements.