RESUMO
Objective:To analyze the status of ethical management of biobanks in Shanghai public hospitals. Methods :A questionnaire survey on ethical management of biobanks was conducted in 9 representative ethics com-mittees, which were established in public hospitals with biobanks in Shanghai. Results: The ethics committees in Shanghai public hospitals had paid relatively high attention to ethical review of protocols were related to biobanks. Nonetheless, the ethical supervision and training on biobanks in Shanghai public hospitals should be enhanced. Con-clusion:The unified ethical guideline on biobanks should be developed in Shanghai for strengthening the standard-ized ethical management and ethics training to promote the development and use of biological samples library re-sources.
RESUMO
A simple, reliable and sensitive liquid chromatography-isotope dilution mass spectrometry (LC-ID/MS) was developed and validated for quantification of olanzapine in human plasma. Plasma samples (50 microL) were extracted with tert-butyl methyl ether and isotope-labeled internal standard (olanzapine-D3) was used. The chromatographic separation was performed on XBridge Shield RP 18 (100 mm x 2.1 mm, 3.5 microm, Waters). An isocratic program was used at a flow rate of 0.4 m x min(-1) with mobile phase consisting of acetonitrile and ammonium buffer (pH 8). The protonated ions of analytes were detected in positive ionization by multiple reactions monitoring (MRM) mode. The plasma method, with a lower limit of quantification (LLOQ) of 0.1 ng x mL(-1), demonstrated good linearity over a range of 0.1 - 30 ng x mL(-1) of olanzapine. Specificity, linearity, accuracy, precision, recovery, matrix effect and stability were evaluated during method validation. The validated method was successfully applied to analyzing human plasma samples in bioavailability study.