scholarly journals Nonclinical Study Sponsor

2020 ◽  
Author(s):  
Keyword(s):  
2012 ◽  
Vol 28 (1) ◽  
pp. 11-18 ◽  
Author(s):  
Marcus Roth ◽  
Philipp Hammelstein

Based on the conception of sensation seeking as a need rather than a temperamental trait ( Hammelstein, 2004 ), we present a new assessment method, the Need Inventory of Sensation Seeking (NISS), which is considered to assess a motivational disposition. Three studies are presented: The first examined the factorial structure and the reliability of the German versions of the NISS; the second study compared the German and the English versions of the NISS; and finally, the validity of the NISS was examined in a nonclinical study and compared to the validity of conventional methods of assessing sensation seeking (Sensation Seeking Scale – Form V; SSS-V). Compared to the SSS-V, the NISS shows better reliability and validity in addition to providing new research possibilities including application in experimental areas.


2015 ◽  
Vol 14 (4) ◽  
pp. 65-72 ◽  
Author(s):  
V. A. Chaley ◽  
O. I. Konyaeva ◽  
N. P. Ermakova ◽  
A. A. Nikolina ◽  
V. M. Bukhman ◽  
...  

The paper presents the results of the study of «acute» toxicity and some results of the study of «subchronic» toxicity of Ormustin, a new anticancer drug belonging to nitrosourea class, in small laboratory animals. In the experiments the laboratory animals - hybrid mice (C57Bl/6J×DBA/2)F1 male and female and outbred male and female rats have been used. On the results of study has been obtained the calculated toxic doses of Ormustin at intravenous administration of the drug in mice and rats; has been given the preliminary assessment of the impact of Ormustin on organs and systems of rats at multiple intravenous administration.


2021 ◽  
Author(s):  
Thomas Charrel ◽  
Bernard Greillier

The purpose of this nonclinical study was to evaluate the performance (in terms of vein occlusion) and the local tissue effects of echo-guided HIFU (High Intensity Focused Ultrasound) treatments in sheep’s saphenous veins.HIFU treatments were used to treat 4 saphenous veins. Two HIFU doses were evaluated 4s/60J and 7s/105J with and without tumescence injection in perivenous tissues. Before and after treatment, ultrasound scans were performed (at Day 0, 3, 7 and 21). Sheep were then euthanized at D21. Local tissue effects were evaluated based on the macroscopic observations, while the evaluation of the device performance was based on ultrasonic scan.Macroscopically throughout the study duration, for dose of 4s/60J and with tumescence, significant lumens diameter reduction of 84% was observed without skin burns. For doses of 4s/60J without tumescence and 7s/105J skin burns of slight to severe grade was observed along the vein, while no thrombus nor lumen reduction were observed.


2020 ◽  
Vol 48 (3) ◽  
pp. 524-528
Author(s):  
Sophie Nelissen ◽  
Joost Lensen ◽  
Erio Barale-Thomas

We identified the presence of Renaut bodies in an unusual location in Beagle dogs on a 3-month nonclinical toxicity study. These peculiar structures are commonly reported as a background finding in the sciatic nerve of dogs. In our study, however, they were also observed in autonomic nerves surrounding the adrenal gland, a location in which they have not been reported before. The incidence in both locations were 8 of 32 Beagle dogs in the sciatic nerve and 6 of 40 Beagle dogs around the adrenal gland in the dosing and/or recovery phases of the study.


Author(s):  
Lokesh Khushalrao Tijare ◽  
Rangari Nt ◽  
Mahajan Un

ABSTRACTIn this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should beapplied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and theirmetabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokineticstudies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigatedto decide the extent to which environment, matrix, or procedural variables can interfere the estimation of analyte in the matrix from the time of setup to the time of analysis. Techniques such as high pressure liquid chromatography (HPLC) and liquid chromatography coupled with double massspectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographicmethods are HPLC and gas chromatography have been mainly used for the bioanlysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy,precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposedto add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug,concentration and its metabolite.Keywords: Method development, Clinical and nonclinical study, Analyte, Validation of bioanlysis techniques, Validation parameter.


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