To determine the pharmacokinetics of gemcitabine (2',2'-difluorodeoxycytidine) in Chinese non-small-cell lung cancer (NSCLC) patients. Six study subjects were administered gemcitabine at a fixed dose rate of 10 mg/m2 per min (1200 mg/m2,two hours infusion) and carboplatin, and plasma gemcitabine concentrations were measured by ion-pair reversed-phase high-performance liquid chromatography (HPLC). 3P97 Pharmaceutical Kinetics Software was used for the calculation of pharmacokinetic parameters. The obtained mean parameters, elimnation half life (t1/2) (10.67±3.38 min), area under the curve hematologic toxicology result showed that the regimen was effective on and tolerated by the patients.

To determine the pharmacokinetics of gemcitabine (2',2'-difluorodeoxycytidine) in Chinese non-small-cell lung cancer (NSCLC) patients. Six study subjects were administered gemcitabine at a fixed dose rate of 10 mg/m(2) per min (1200 mg/m(2), two hours infusion), and carboplatin and plasma gemcitabine concentrations were measured by ion-pair reversed-phase high-performance liquid chromatography (HPLC). 3P97 Pharmaceutical Kinetics Software was used for the calculation of pharmacokinetic parameters. The obtained mean parameters, elimination half life (t(1/2)) (10.67+/-3.38 min), area under the curve (AUC) (7.55+/-1.53 (microg x h)/ml), and clearance (CL) (3940.05+/-672.08 ml/min), were consistent with those reported in literature. The hematologic toxicology result showed that the regimen was effective on and tolerated by the patients.
Adolescent ; Adult ; Aged ; Carcinoma, Non-Small-Cell Lung ; blood ; China ; Deoxycytidine ; administration & dosage ; analogs & derivatives ; blood ; pharmacokinetics ; Female ; Humans ; Male ; Middle Aged ; Time Factors

This study presents a rapid, specific and sensitive liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay for determination of risperidone (RIS) in human serum using paroxetine as an internal standard (IS). An Alltima-C18 column (2.1 mmx100 mm, 3 microm) and a mobile phase consisting of 0.1% formic acid-acetonitrile (40:60, v/v) were used for separation. The analysis was performed by selected reaction monitoring (SRM) method, and the peak area of the m/z 411.3-->191.1 transition for RIS was measured versus that of the m/z 330.1-->192.1 transition for IS to generate the standard curves. The assay linearity of RIS was confirmed over the range 0.25 approximately 50.00 ng/ml and the limit of quantitation was 0.05 ng/ml. The linear range corresponds well with the serum concentrations of the analytes obtained in clinical pharmacokinetic studies. Intraday and interday relative standard deviations were 1.85% approximately 9.09% and 1.56% approximately 4.38%, respectively. The recovery of RIS from serum was in the range of 70.20% approximately 84.50%. The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test versus reference products) in 18 healthy male Chinese volunteers. The result suggests that two formulations are bioequivalent.
Adolescent ; Adult ; Antipsychotic Agents ; blood ; pharmacokinetics ; Area Under Curve ; China ; Chromatography, High Pressure Liquid ; methods ; Drug Stability ; Humans ; Male ; Mass Spectrometry ; methods ; Reference Standards ; Reproducibility of Results ; Risperidone ; blood ; pharmacokinetics ; Time Factors

Objective To establish a physiologically based pharmacokinetic (PBPK) model and predict the pharmacokinetics (PK) of theophylline in premature infants.Methods Collected the drug-specific properties and clinical trial data of theophylline from published literatures,theophylline PBPK model was established by GastroPlus simulation technology.The accuracy and applicability of model were verified in different type populations.It was also verified to predict premature population.The model was used to predict the PK of theophylline in each preterm after parameter optimization.Results It was verified with good accuracy and applicability.The area under curve AUCsim/AUCobs ratio was 0.85-1.15 and the coefficient of determination (R2) was greater than 0.85.It's less errors and good fit of the simulated value and observed data in each preterm.Conclusion The PBPK model of theophylline established by GastroPlus can reflect the PK process of theophylline in premature infants and provide a reference for theophylline individualized medication.It will be able to improve the model accuracy by the supplement of the important physiological and anatomical data of premature and infants in China.

Objective To clarify and analyze the reasons for failure in screening healthy menopausal female in a bioequivalence trial.Methods To summarize and clarify the data of 185 healthy menopausal female subjects participating in a bioequivalence trial of estradiol valerate conducted,and summarize the reasons for screening failure.Results The main reasons for screening failure include laboratory tests(32.04％),gynecological transvaginal color Doppler ultrasound(16.57％),vital signs(14.36％),chest computed tomography(CT,11.60％),and medical history/medication history(7.73％).Conclusion Screening failures in healthy menopausal female subjects were characterized mainly by abnormal gynecological transvaginal color Doppler ultrasound and non-compliance with basal hormone levels compared to generally healthy subjects.