<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Aline Baldo</style></author><author><style face="normal" font="default" size="100%">van den Akker, Eric</style></author><author><style face="normal" font="default" size="100%">Bergmans, Hans E</style></author><author><style face="normal" font="default" size="100%">Lim, Filip</style></author><author><style face="normal" font="default" size="100%">Katia Pauwels</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">General considerations on the biosafety of virus-derived vectors used in gene therapy and vaccination.</style></title><secondary-title><style face="normal" font="default" size="100%">Curr Gene Ther</style></secondary-title><alt-title><style face="normal" font="default" size="100%">Curr Gene Ther</style></alt-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Animals</style></keyword><keyword><style  face="normal" font="default" size="100%">Clinical Trials as Topic</style></keyword><keyword><style  face="normal" font="default" size="100%">Genetic Therapy</style></keyword><keyword><style  face="normal" font="default" size="100%">Genetic Vectors</style></keyword><keyword><style  face="normal" font="default" size="100%">Hazardous Substances</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Organisms, Genetically Modified</style></keyword><keyword><style  face="normal" font="default" size="100%">Risk Assessment</style></keyword><keyword><style  face="normal" font="default" size="100%">Vaccination</style></keyword><keyword><style  face="normal" font="default" size="100%">Viruses</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2013</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2013 Dec</style></date></pub-dates></dates><number><style face="normal" font="default" size="100%">394</style></number><volume><style face="normal" font="default" size="100%">13</style></volume><pages><style face="normal" font="default" size="100%">385-94</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;This introductory paper gathers general considerations on the biosafety of virus-derived vectors that are used in human gene therapy and/or vaccination. The importance to assess the potential risks for human health and the environment related to the use of genetically modified organisms (GMO) in this case genetically modified viral vectors is highlighted by several examples. This environmental risk assessment is one of the requirements within the European regulatory framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental risk assessment of genetically modified virus-derived vectors have been developed.&lt;/p&gt;</style></abstract><issue><style face="normal" font="default" size="100%">6</style></issue><custom1><style face="normal" font="default" size="100%">https://www.ncbi.nlm.nih.gov/pubmed/24195604?dopt=Abstract</style></custom1><section><style face="normal" font="default" size="100%">385</style></section></record></records></xml>