OBJECTIVE: In this presented work, an analytical method by gas chromatography coupled with flame ionization detection (GC-FID) has been developed to determine organic solvents in radiopharmaceutical samples. The effect of injection holding time, temperature variation in the injection port, and the column temperature on the analysis time and resolution (R ≥ 1.5) of ethanol and acetonitrile was studied extensively.
METHODS: The experimental conditions were optimized with the aid of further statistical analysis; thence, the proposed method was validated following the International Council for Harmonisation (ICH) Q2 (R1) guideline.
RESULTS: The proposed analytical method surpassed the acceptance criteria including the linearity > 0.990 (correlation coefficient of R2), precision < 2%, LOD, and LOQ, accuracy > 90% for all solvents. The separation between ethanol and acetonitrile was acceptable with a resolution R > 1.5. Further statistical analysis of Oneway ANOVA revealed that the increment in injection holding time and variation of temperature at the injection port did not significantly affect the analysis time. Nevertheless, the variation in injection port temperature substantially influenced the resolution of ethanol and acetonitrile peaks (p < 0.05).
CONCLUSION: The proposed analytical method has been successfully implemented to determine the organic solvent in the [18F]fluoro-ethyl-tyrosine ([18F]FET), [18F]fluoromisonidazole ([18F]FMISO), and [18F]fluorothymidine ([18F]FLT).
METHODS: Literature search was performed using 6 electronic databases (PubMed, Scopus, Ovid MEDLINE, EconLit, National Health Service Economic Evaluation Database, and ISI Web of Knowledge). The final search was performed in October 2018. All potential economic studies were then checked for eligibility. The reporting and methodological qualities of each study were independently assessed by 2 authors of this review, using the Consolidated Health Economic Evaluation Reporting Standards, Drummond, and Philips checklists. To compare the different currencies used in these studies, all costs were converted into US dollars (2016).
RESULTS: A total of 6 studies were included; most of them were performed from the healthcare provider perspective. The incremental cost-effectiveness ratio for evaluation performed for a lifetime horizon were reported at $8573 and $20 816 per quality-adjusted life-year in 2 studies. The model outcome was generally sensitive to the changes in trastuzumab drug acquisition cost and discount rate, as well as its clinical effectiveness. For the quality assessment, all studies fulfilled more than 50% of the requirements in the Consolidated Health Economic Evaluation Reporting Standards, Drummond, and Philips checklists.
CONCLUSIONS: Adjuvant trastuzumab therapy is considered a cost-effective option for early breast cancer in Asian countries including China, Iran, Japan, Singapore, and Taiwan. All studies were generally well conducted. Economic evaluations from the societal perspective, with inclusion of indirect and informal care costs, are warranted to facilitate informed decision making among policy makers.
METHODS: Using a prospective randomised controlled single-blinded study design, 164 patients scheduled for colonoscopy were allocated to two groups (n = 82 patients in each) to receive either the conventional PEG volume (3 L, control group) or the low volume (2 L, intervention group). The Boston Bowel Preparation Scale (BBPS), a validated scale for assessing bowel cleanliness during colonoscopy, was used to score bowel cleanliness in three colon segments. Secondarily, colonoscopy completeness, tolerability to drinking PEG and the duration of colonoscopy were compared between the groups.
RESULTS: There were no statistically significant differences between the two intervention groups in terms of bowel cleanliness (P = 0.119), colonoscopy completion (P = 0.535), tolerability (P = 0.190) or the amount of sedation/analgesia required (midazolam, P = 0.162; pethidine, P = 0.708). Only the duration of colonoscopy differed between the two groups (longer duration in the control group, P = 0.039).
CONCLUSION: Low-volume (2 L) PEG is as effective as the standard 3 L solution in bowel cleaning before colonoscopy; however, the superiority of either solution could not be established.