Filgrastim is used to accelerate hematopoietic recovery after ABMT （allogeneic bone marrow transplantation）. Its impact on the total cost of patient care remains to be explored. We therefore undertook a cost effecti...Filgrastim is used to accelerate hematopoietic recovery after ABMT （allogeneic bone marrow transplantation）. Its impact on the total cost of patient care remains to be explored. We therefore undertook a cost effectiveness analysis in the context of a randomized single blinded clinical trial of Filgrastim versus placebo in post ABMT. A primary endpoint, duration of myelosuppression, and three secondary end points （number of days of fever, length of hospital stay, survival at one hundred days） were used to assess efficacy. Direct costs were evaluated and allowed the calculation of the ICER （incremental cost-effectiveness ratios） for the major endpoint of the trial. Sixteen patients were included in the study. The duration of myelosuppression was significantly decreased in the Filgrastim arm with medians of 15 days vs. 19 days in the placebo arm （p = 0.023）. Cost analysis showed no statistically significant difference between the two arms. According to the calculation of ICER, Filgrastim was more costly and more effective than placebo for the number of days of aplasia avoided and the number of days with fever avoided. Placebo strictly dominated filgrastim for days of hospitalization avoided. Filgrastim has proven effective in reducing the duration of aplasia without increasing costs.展开更多
A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica ge...A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.展开更多
文摘Filgrastim is used to accelerate hematopoietic recovery after ABMT （allogeneic bone marrow transplantation）. Its impact on the total cost of patient care remains to be explored. We therefore undertook a cost effectiveness analysis in the context of a randomized single blinded clinical trial of Filgrastim versus placebo in post ABMT. A primary endpoint, duration of myelosuppression, and three secondary end points （number of days of fever, length of hospital stay, survival at one hundred days） were used to assess efficacy. Direct costs were evaluated and allowed the calculation of the ICER （incremental cost-effectiveness ratios） for the major endpoint of the trial. Sixteen patients were included in the study. The duration of myelosuppression was significantly decreased in the Filgrastim arm with medians of 15 days vs. 19 days in the placebo arm （p = 0.023）. Cost analysis showed no statistically significant difference between the two arms. According to the calculation of ICER, Filgrastim was more costly and more effective than placebo for the number of days of aplasia avoided and the number of days with fever avoided. Placebo strictly dominated filgrastim for days of hospitalization avoided. Filgrastim has proven effective in reducing the duration of aplasia without increasing costs.
文摘A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.
