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He X.-R.,Peking University | He X.-R.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Liu Z.-H.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Ji S.-M.,Peking University | And 4 more authors.
Yaoxue Xuebao | Year: 2014

Population pharmacokinetics of vancomycin (VAN) in the Chinese patients was described by using nonlinear mixed-effects modeling (NONMEM). 619 VAN serum concentrations data from 260 patients including 177 males and 83 females were collected separately from two centers. A one-compartment model was used to describe this sparse data. No significant difference was observed between two center datasets by introducing SID covariate. The final model was as CL = (θbese+θmax×(1-e(-θ1×CLCr)))×θAge (Age/73) and V = θv × ×θAge (Age/73). The creatinine clearance (CLCr) and Age were identified as the most significant covariate in the final model. Typical values of clearance (CL) and volume of distribution (V) in the final model were 2.91 Lh-1 and 54.76 L, respectively. Internal model validation by Bootstrap and NPDE were performed to evaluate the robustness and prediction of the final model. The median and 95% confidence intervals for the final model parameters were based on 1000 Bootstraps. External model evaluation was conducted using an independent dataset that consisted of 34 patients to predict model performance. Pharmacodynamic assessment for VAN by AUC 0-24 h to MIC ratios of over 400 was considered to be the best to predict treatment outcomes for patients. AUC 0-24 h was calculated by clearance based on the above population model. The results indicate that the conventional dosing regimen probably being suboptimal concentrations in aged patients. The approach via population pharmacokinetic of VAN combined with the relationship of MIC, Age, CLCr and AUC0-24h/MIC can predict the rational dose for attaining efficacy. Source


Yan B.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Li K.-X.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation
Chinese Journal of New Drugs | Year: 2015

Through retrieving a large number of literatures about clinical research published in recent years, we investigated the reasons for similarities and differences among the published data, and the data quality and potential issues from phase I clinical trials. Then we proposed reasonable suggestions to improve industry standards, quality of clinical research in China and relevant regulatory policies. We also provided warning information for researchers, sponsors, regulators and magazines. © 2015, Chinese Journal of New Drugs Co. Ltd. All right reserved. Source


Xue W.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Liu Y.,Peking University | Qi W.-Y.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Gao Y.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | And 3 more authors.
Journal of Asian Natural Products Research | Year: 2016

The present study aimed to investigate pharmacokinetics of Rg1 in rat medial prefrontal cortex (mPFC), hippocampus (HIP), and lateral ventricle (LV) after subcutaneous injection. For the first time, intracerebral pharmacokinetics of Rg1 was studied in freely moving rats by microdialysis technique. Rg1 concentrations in dialysates were detected by a liquid chromatography–tandem mass spectrometry (LC-MS/MS) method and were revised using in vivo probe-recovery in HIP and LV. The pharmacokinetic parameters were then determined using non-compartmental models. Since the in vivo recoveries remained stable in HIP and LV during 9 h dialysis, average recoveries were used to revise dialysate concentrations. After dosing, Rg1 was soon detected in brain extracellular fluid (bECF) and cerebrospinal fluid (CSF). The elimination of Rg1 was significantly slower in mPFC than in HIP and LV, and significantly greater AUC was obtained in mPFC than in HIP. Rg1 kinetics in bECF and CSF indicate that Rg1 can go across the blood-brain barrier (BBB) and the blood-cerebrospinal fluid barrier (BCSFB), and then immediately distribute to learning and memory-related regions in brain, which may lead to rapid pharmacological onset. There may be active transport and target-mediated disposition of Rg1 in the CNS, which need to be further clarified. © 2016 Informa UK Limited, trading as Taylor & Francis Group. Source


Xu S.,Beijing Hospital | Xu S.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Jin P.-F.,Beijing Hospital | Jin P.-F.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | And 4 more authors.
Chinese Journal of New Drugs | Year: 2015

Literature analysis and review on the chemical substances illegally adulterated in traditional Chinese medicines and health foods were conducted, and the research advances on the adulterated chemical substances, the analytical methods and technical development directions as well as the supervision strategies were presented. The results indicated that the adulterated chemical substances mainly included sexual function enhancing drugs, sedative-hypnotic drugs, antidiabetic drugs, antiviral drugs, antibiotics, antipyretic drugs, analgesics and anti-inflammatory drugs, glucocorticoids, antitussive drugs, antihypertensive drugs, weight-loss drugs, and gastric acid secretion inhibiting drugs. The analytical methods involved the physico-chemical analysis, thin layer chromatography (TLC) analysis, high-performance liquid chromatography analysis, liquid chromatography-mass spectrometry analysis, gas chromatography-mass spectrometry analysis, capillary electrophoresis chromatography analysis, ion mobility chromatography analysis, infrared spectroscopy (including near-infrared spectroscopy) analysis and Raman spectroscopy analysis. Physico-chemical and TLC analysis could only be used for the preliminary screening. For the fast site analysis and screening, IR, RS and hollow fiber solvent microextraction-mobile HPLC are suitable choices. HPLC and LC-MS/MS techniques are suitable for the accurate laboratory screening and quantitative analysis. In addition to the development of analytical techniques, it is also very important to strengthen the supervisions of illegally adulterated chemical substances. ©, 2015, Chinese Journal of New Drugs Co. Ltd. All right reserved. Source


Li M.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Hu X.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation | Li K.-X.,Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation
Chinese Journal of New Drugs | Year: 2013

The fatal adverse events caused by benoxaprofen in the 1980s in the UK and the United States mostly occurred in the elderly. Ignoring the special pharmacokinetic property in the elderly population was the direct cause of this event. The study object of clinical pharmacokinetics should represent the practical clinical populations. However, either in the past or present, the pharmacokinetic data in the elderly population was seriously inadequate or missing, especially for drugs targeting age-related diseases. The lack of clinical research data in the elderly population will limit the clinical treatment of the elderly population, and may easily lead to potential safety risks. With the acceleration of the process of population aging, regulators, sponsors, physicians and pharmacists come to realize the importance and necessity of pharmacokinetic studies in the elderly. Understanding the pharmacokinetics of drugs in special populations such as the elderly can provide the necessary data to support rational drug therapy. Source

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