Environmental Metabolomics: With the Perspective of Marine Toxicology Assessment

Author(s):  
Ninian Prem Prashanth Pabbathi ◽  
Neelam M. Nathani ◽  
Indra Ramjibhai Gadhvi ◽  
Mootapally Chandrashekar
2001 ◽  
Vol 20 (10) ◽  
pp. 533-550 ◽  
Author(s):  
V Ciaravino ◽  
T McCullough ◽  
A D Dayan

The pathogen inactivation process developed by Cerus and Baxter Healthcare Corporations uses the psoralen, S-59 (amotosalen) in an ex vivo photochemical treatment (PCT) process to inactivate viruses, bacteria, protozoans, and leukocytes in platelet concentrates and plasma. Studies were performed by intravenous infusion of S-59 PCT formulations-compound adsorption device (CAD) treatment and with non-UVA illuminated S-59, using doses that were multiples of potential clinical exposures. The studies comprised full pharmacokinetic, single and repeated-dose (up to 13 weeks duration) toxicity, safety pharmacology (CNS, renal, and cardiovascular), reproductive toxicity, genotoxicity, carcinogenicity testing in the p53- mouse, vein irritation, and phototoxicity. No specific target organ toxicity (clinical or histopathological), reproductive toxicity, or carcinogenicity was observed. S-59 and/or PCT formulations demonstrated CNS, ECG, and phototoxicity only at supraclinical doses. Based on the extremely large safety margins (>30,000 fold expected clinical exposures), the CNS and ECG observations are not considered to have any toxicological relevance. Additionally, after a complete assessment, mutagenicity and phototoxicity results are not considered relevant for the proposed use of INTERCEPT platelets. Thus, the results of an extensive series of in vitro and in vivo studies have not demonstrated any toxicologically relevant effects of platelet concentrates prepared by the INTERCEPT system.


2016 ◽  
Vol 130 ◽  
pp. 234-239 ◽  
Author(s):  
Shuai Wang ◽  
He Fang ◽  
Xiaofeng Yi ◽  
Zhiqun Xu ◽  
Xiaodong Xie ◽  
...  

Transfusion ◽  
2003 ◽  
Vol 43 (10) ◽  
pp. 1481-1492 ◽  
Author(s):  
Vic Ciaravino ◽  
Tim McCullough ◽  
George Cimino

Author(s):  
Terry Ching ◽  
Yi-Chin Toh ◽  
Michinao Hashimoto ◽  
Yu Shrike Zhang

Author(s):  
Giovanni Mastroianni ◽  
Monica Scognamiglio ◽  
Chiara Russo ◽  
Antonio Fiorentino ◽  
Margherita Lavorgna

2015 ◽  
Vol 24 (11) ◽  
pp. 1284-1296 ◽  
Author(s):  
Laura Suter-Dick ◽  
Paula M. Alves ◽  
Bas J. Blaauboer ◽  
Klaus-Dieter Bremm ◽  
Catarina Brito ◽  
...  

2006 ◽  
Vol 53 (1) ◽  
pp. 11-19 ◽  
Author(s):  
Marshall Leslie Tattersall ◽  
Michael Dymond ◽  
Tim Hammond ◽  
Jean-Pierre Valentin

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