Central Laboratory in Paediatric Clinical Trials

2006 ◽  
pp. 78-86
Author(s):  
Marietta M. Henry
2020 ◽  
Vol 16 (S5) ◽  
Author(s):  
Michal J. Figurski ◽  
Shaila Berlas ◽  
Magdalena Korecka ◽  
Tatiana M. Foroud ◽  
Doug R. Galasko ◽  
...  

Bioanalysis ◽  
2019 ◽  
Vol 11 (20) ◽  
pp. 1859-1866 ◽  
Author(s):  
Melanie Anderson

In quantitative bioanalysis, ensuring sample integrity through the life cycle of a sample is crucial for providing reliable data. Sponsors must develop proper collection procedures to ensure high sample quality. Collection procedures should mitigate sample variability and stability concerns. Sample stability concerns can be managed with appropriate stabilization approaches like the addition of preservative, environmental exposure (temperature, humidity, light controls) and timely analysis with more frequent shipping. It is important that the bioanalytical scientist communicates specific needs to internal operations groups, the central laboratory and clinical sites. In large global trials, this is logistically challenging given the large number of sites and the potential language barriers. Several case studies presented below will illustrate logistical challenges with unstable compounds and unique matrices for LC–MS/MS workflows.


1996 ◽  
Vol 78 (9) ◽  
pp. 1074-1076 ◽  
Author(s):  
Gary E. Raskob ◽  
Sherri S. Durica ◽  
Willis L. Owen ◽  
Philip C. Comp

Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.


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