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SHINYOUNG GEUN,Henri Meijering,Fred H. van Heuveln,Jaap Wieling,Jason Halladay,Srikumar Sahasranaman,Cornelis E.C.A. Hop 대한임상약리학회 2015 Translational and Clinical Pharmacology Vol.23 No.2
The development and validation of a method for the determination of concentrations of thiocyanatein human plasma are described here. A modified colorimetric method of Bowler was used withthe following alteration in Monica Manual, Part III. In order to obtain the same sensitivity in lowamounts of clinical samples, quartz SUPRASIL® micro cuvettes have been used. The quantitationrange was between 25–500 μM. Accuracy and precision of the quality control samples, linearity ofthe calibration curve, dilution, spike recovery and stability under various conditions were evaluatedin the validation of the method and all demonstrated acceptable results. All validation results metgood laboratory practice acceptance and FDA requirements to be acceptable for application in clinicaltrials. The validated method has been used for a Phase I clinical study in cancer patients orallyadministered with either 60 mg or 80 mg of GDC-0425 containing a cyanide (CN-) group. The thiocyanatelevels from patients before and after drug administration showed no clinically significantdifferences