Objective To establish HPLC method for fast, effective, simultaneous determination of Vancomycin and Norvancomycin in serum. Methods The separation was achieved on the Hypersil ODS2(250 mm ×4.6 mm,5μm)with methanol-acetonitrile-a mixture of potassium phosphate (9.5:2.5:88) as the mobile phase.The flow rate was 1.0 mL/min.The UV detecting wavelength was 280 nm.The temperature of the column was 35 ℃. Vancomycin and Norvancomycin were used as the internal standard for each other .Results Vancomycin and Norvancomycin blood concentration were in well linearity in the range of 1.25-100μg/mL,R2 =0.9996.The average method recovery rate of three concentrations were 96.88%,99.50%,105.01%respectively, the average method recovery rate of three concentrations were 94.40%,103.90,103.81%respectively, the intra-day and inter-day RSD were less than 5%.Conclusion The HPLC method is proved to be simple,sensitive, accurate and precise in which little blood sample is taken, thus it is suitable for the therapeutic drug monitoring(TDM) and pharmacokinetic study of Vancomycin and Norvancomycin.

Biomarkers, Tumor ; Endocrine Glands ; pathology ; secretion ; Hormones ; metabolism ; Humans ; Neuroendocrine Tumors ; genetics ; pathology ; therapy ; Pathology ; methods ; trends

Autopsy ; China ; Diagnosis, Differential ; Humans ; Immunohistochemistry ; Molecular Biology ; Molecular Diagnostic Techniques ; methods ; Pathology, Clinical ; methods ; organization & administration

Dendritic Cells ; pathology ; Histiocytes ; pathology ; Histiocytosis, Langerhans-Cell ; pathology ; Humans ; Keratins ; analysis ; Langerhans Cells ; pathology ; Lymphoma, Large B-Cell, Diffuse ; pathology ; Sarcoma ; chemistry ; classification ; pathology

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Outsourced Services ; Quality Control

Humans ; Molecular Diagnostic Techniques ; standards ; Quality Control

Female ; Humans ; Male ; Precision Medicine ; methods ; standards ; trends ; Specialization

Evaluation Studies as Topic ; Immunohistochemistry ; methods ; standards ; Reference Standards

China ; Gene Rearrangement ; Humans ; Immunohistochemistry ; Lymphoma ; classification ; diagnosis ; genetics ; pathology ; Quality Control ; Staining and Labeling ; World Health Organization

Antibodies, Monoclonal ; therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic Agents ; therapeutic use ; Erlotinib Hydrochloride ; Humans ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Neoplasms ; drug therapy ; genetics ; metabolism ; Quinazolines ; therapeutic use ; Receptor, Epidermal Growth Factor ; antagonists & inhibitors ; genetics ; metabolism ; Trastuzumab