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A027P bioanalytical method validation and TK samples analysis

中国药理学与毒理学杂志 2013年第3期 544-545页

作者： HUANG Li-ming HONG Jin-chuan PAN Guo-yu Centre for Drug Safety Evaluation and Research Shanghai Institute of Materia Medica

OBJECTIVE To develop and fully validate an hplc-ms /ms method for the determination of test compound A027P in acidified cynomolgus monkey plasma and the TK sample bioanalysis *** AND RESULTS A simple and sensitive hplc-ms /ms method was developed and fully validated in CDSER to determine A027P concentration in cynomolgus monkey *** method was qualified in the range 1.00-1000 μmol·L-1 and the lower limit of quantification set at 1.00 μmol·*** can be quantified after dilution up to 10 times with blank acidified monkey plasma into the calibration *** plasma concentration of a compound was determined by hplc-ms /ms after oral administration to cynomolgus monkey in the MTD *** parameters were calculated by software WinNonlin *** results were compared to Covance and the data correlated very *** A simple,sensitive and specific hplc-ms /ms method was established and fully *** is suitable for the determination of test compound in acidified cynomolgus *** the MTD study groups,all animals dosed with A027P were exposed to *** exposure to A027P in terms of AUC(0-24) increased more than in proportion to the dose of A027P in the dose range 10 to 1000 mg·kg-1 in animals for phase *** Cmax and AUC(0-24) was lower after repeated dosing compared to single dosing with the exception of Cmax in dose 1000 *** data suggested there is no accumulation of drug after repeated *** is a possible sex difference in the exposure of A027P.

关键词： full validation hplc-ms /ms TK

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