ASO Author Reflections: Development and Validation of Distal Cholangiocarcinoma Early Recurrence (DICER) Score: Results from the US Extrahepatic Biliary Malignancy Consortium

Background: Conivaptan inhibits two of vasopressin receptor (vasopressin receptor V1a and V2). Conivaptan is used for the treatment of hyponatremia, and in some instances, for the treatment of the heart failure. Methods: The present study aimed to develop a simple, sensitive, and accurate HPLC with ultraviolet detection for the assay of conivaptan (CON) in mouse plasma using bisoprolol as internal standard (IS). A precipitation procedure was used to extract CON and the IS from the mouse plasma. CON was chromatographically separated using a C18 analytical column at 25°C. The separation was carried out using a mixture of phosphate buffer (50 mM): acetonitrile (60: 40, v/v, pH 4.5) with a flow rate of 1.0 mL/min and detection was performed at 240 nm. Results: The assay was validated according to the US Food and Drug (FDA) guidelines. The method demonstrated linearity over a concentration range of 150 - 2000 ng/mL (correlation coefficient: r 2 = 0.9985). The mean recovery of CON from the mouse plasma was 101.13%. All validation parameters for CON were within the acceptable range. Conclusion: The investigated method has been shown to be suitable for estimating the CON in plasma samples, and this method is sensitive and highly selective, allowing the estimation of its concentrations up to the nano-scale. The suggested method was successfully used in a pharmacokinetic study of CON in mouse plasma.

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Elevated NLR in gallbladder cancer and cholangiocarcinoma: Bad cancer or worse patient? Results from the US extrahepatic biliary malignancy consortium

HPB ◽

10.1016/j.hpb.2016.02.256 ◽

2016 ◽

Vol 18 ◽

pp. e109

Author(s):

E. Beal ◽

S. Weber ◽

G. Poultsides ◽

I. Hatzaras ◽

P. Shen ◽

...

Keyword(s):

Gallbladder Cancer ◽

Biliary Malignancy ◽

The Us

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Outcomes after vascular resection during curative resection for hilar cholangiocarcinoma: a multi-institution analysis from the US extrahepatic biliary malignancy consortium

HPB ◽

10.1016/j.hpb.2017.02.209 ◽

2017 ◽

Vol 19 ◽

pp. S26 ◽

Cited By ~ 1

Author(s):

G. Schimizzi ◽

J. Davidson ◽

B. Krasnick ◽

L. Jin ◽

C. Ethun ◽

...

Keyword(s):

Hilar Cholangiocarcinoma ◽

Curative Resection ◽

Vascular Resection ◽

Biliary Malignancy ◽

The Us

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Development and Validation of Nomogram to Predict Very Early Recurrence of Combined Hepatocellular-Cholangiocarcinoma After Hepatic Resection: A Multi-Institutional Study

10.21203/rs.3.rs-1094632/v1 ◽

2021 ◽

Author(s):

Yijun Wu ◽

Hongzhi Liu ◽

Jianxing Zeng ◽

Yifan Chen ◽

Guoxu Fang ◽

...

Keyword(s):

Validation Cohort ◽

Risk Groups ◽

Early Recurrence ◽

Curve Analysis ◽

Multivariable Logistic Regression Analysis ◽

Good Discrimination ◽

Decision Curve Analysis ◽

High Incidence ◽

Combined Hepatocellular Cholangiocarcinoma ◽

Development And Validation

Abstract Background and Objectives Combined hepatocellular cholangiocarcinoma (cHCC) has a high incidence of early recurrence. The objective of this study is to construct a model predicting very early recurrence (VER)(ie, recurrence within 6 months after surgery) of cHCC. Methods 131 consecutive patients from Eastern Hepatobiliary Surgery Hospital served as a development cohort to construct a nomogram predicting VER by using multivariable logistic regression analysis. The model was internally and externally validated in an validation cohort of 90 patients from Mengchao Hepatobiliary Hospital using the C concordance statistic, calibration analysis and decision curve analysis (DCA). Results The VER nomogram contains microvascular invasion(MiVI), macrovascular invasion(MaVI) and CA19-9>25mAU/mL. The model shows good discrimination with C-indexes of 0.77 (95%CI: 0.69 - 0.85 ) and 0.76 (95%CI:0.66 - 0.86) in the development cohort and validation cohort respectively. Decision curve analysis demonstrated that the model are clinically useful and the calibration of our model was favorable. Our model stratified patients into two different risk groups, which exhibited significantly different VER. Conclusions Our model demonstrated favorable performance in predicting VER in cHCC patients.

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Bio analytical method development and validation for Ezetimibe and Pitavastain and its applications to pharmacokinetic studies in Rabbit plasma by using LCMS/MS

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v11i4.4670 ◽

2020 ◽

Vol 11 (4) ◽

pp. 7854-7862

Author(s):

Potturi Ramadevi ◽

Kantipudi Rambabu

Keyword(s):

Method Development ◽

Extraction Process ◽

Pharmacokinetic Studies ◽

Rabbit Plasma ◽

Highly Sensitive ◽

The Us ◽

Positive Mode ◽

Method Development And Validation ◽

Development And Validation ◽

Preparation Techniques

For the gradation of Ezetimibe and Pitavastain in rabbit plasma, a highly sensitive and simple LC-MS/MS assay was developed and witnessed. The chromatographic conditions are isocratic with a waters symmetry C18 (150 x 4.6 mm, 3.5) column in isocratic mode. The detection was carried out using a mobile phase of 0.1 percent formic acid and 60:40 acetonitrile, and the detection was carried out using MS in a positive mode of electrospray ionisation. The valid approach was checked with a linear range of 10-200 ng/ml Ezetimibe and 2-40 ng/ml Pitavastain. The intraday and interday precision values were found to be within reasonable limits. The liquid extraction process is used to remove these drugs from rabbit plasma. And these drugs have been shown to be stable in freeze-thaw, autosampler, and benchtop tests in the future. The fluid chromatography coupled mass spectrometry strategy was approved by the US Food and Drug Administration for quantification of Ezetimibe and Pitavastain in rabbit plasma using D4–ezetimibe and D4–pitavastain as within norms using LC-MS consolidated with quadrupole spectrometer by electro shower ionisation process. The aim of this study is to evaluate the applicability of this approach to ezetimibe and pitavastain at different evaluation levels while taking into account various factors such as instrument stability, precision, and accuracy, sample preparation techniques, instrument calibration, recovery, and matrix effect by using Ezetimibe and Pitavastain, as well as their internal guidelines.

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