scholarly journals Information tools for environmental risk assessment of low level presence

2011 ◽  
Vol 10 (1) ◽  
pp. 1-3 ◽  
Author(s):  
Andrew Roberts
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Low Level ◽  
Information Tools

scholarly journals Environmental Risk Assessment for rVSVΔG-ZEBOV-GP, a Genetically Modified Live Vaccine for Ebola Virus Disease

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 779
Author(s):  
Joan G. Tell ◽  
Beth-Ann G. Coller ◽  
Sheri A. Dubey ◽  
Ursula Jenal ◽  
William Lapps ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Ebola Virus ◽  
Virus Disease ◽  
Genetically Modified ◽  
Ebola Virus Disease ◽  
European Medicines Agency ◽  
Low Level ◽  
Animal Populations

rVSVΔG-ZEBOV-GP is a live, attenuated, recombinant vesicular stomatitis virus (rVSV)-based vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus. As a replication-competent genetically modified organism, rVSVΔG-ZEBOV-GP underwent various environmental evaluations prior to approval, the most in-depth being the environmental risk assessment (ERA) required by the European Medicines Agency. This ERA, as well as the underlying methodology used to arrive at a sound conclusion about the environmental risks of rVSVΔG-ZEBOV-GP, are described in this review. Clinical data from vaccinated adults demonstrated only infrequent, low-level shedding and transient, low-level viremia, indicating a low person-to-person infection risk. Animal data suggest that it is highly unlikely that vaccinated individuals would infect animals with recombinant virus vaccine or that rVSVΔG-ZEBOV-GP would spread within animal populations. Preclinical studies in various hematophagous insect vectors showed that these species were unable to transmit rVSVΔG-ZEBOV-GP. Pathogenicity risk in humans and animals was found to be low, based on clinical and preclinical data. The overall risk for non-vaccinated individuals and the environment is thus negligible and can be minimized further through defined mitigation strategies. This ERA and the experience gained are relevant to developing other rVSV-based vaccines, including candidates under investigation for prevention of COVID-19.

scholarly journals Environmental risk assessment of transgene products using honey bee (Apis mellifera) larvae

Apidologie ◽  
2003 ◽  
Vol 34 (2) ◽  
pp. 139-145 ◽  
Author(s):  
Henrik F. Brodsgaard ◽  
Camilla J. Brodsgaard ◽  
Henrik Hansen ◽  
G�bor L. L�vei
Keyword(s):  
Risk Assessment ◽  
Apis Mellifera ◽  
Honey Bee ◽  
Environmental Risk ◽  
Environmental Risk Assessment

The zebrafish embryo model in environmental risk assessment—applications beyond acute toxicity testing

2008 ◽  
Vol 15 (5) ◽  
pp. 394-404 ◽  
Author(s):  
Stefan Scholz ◽  
Stephan Fischer ◽  
Ulrike Gündel ◽  
Eberhard Küster ◽  
Till Luckenbach ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Acute Toxicity ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Zebrafish Embryo ◽  
Toxicity Testing ◽  
Acute Toxicity Testing

Recommendations on the Environmental Risk Assessment of Pharmaceuticals - Effect Characterization

2007 ◽  
Vol preprint (2009) ◽  
pp. 1
Author(s):  
Heike Schmitt ◽  
Tatiana Boucard ◽  
Jeanne Garric ◽  
John Jensen ◽  
Joanne Parrott ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment

Glossary of terms used in developmental and reproductive toxicology (IUPAC Recommendations 2016)

2016 ◽  
Vol 88 (8) ◽  
pp. 713-830
Author(s):  
John H. Duffus ◽  
Michael Schwenk ◽  
Douglas M. Templeton
Keyword(s):  
Risk Assessment ◽  
Reproductive Biology ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Primary Objective ◽  
Human Reproduction ◽  
Reproductive Systems ◽  
Teratogenic Effects ◽  
Male And Female ◽  
Medical Practitioners

Abstract The primary objective of this glossary is to give clear definitions for those who contribute to studies relevant to these disciplines, or who must interpret them, but are not themselves reproductive physiologists or physicians. This applies especially to chemists who need to understand the literature of reproductive and teratogenic effects of substances without recourse to a multiplicity of other glossaries or dictionaries. The glossary includes terms related to basic and clinical reproductive biology and teratogenesis, insofar as they are necessary for a self-contained document, particularly terms related to diagnosing, measuring, and understanding the effects of substances on the embryo, the fetus, and on the male and female reproductive systems. The glossary consists of about 1200 primary alphabetical entries and includes Annexes of common abbreviations and examples of chemicals with known effects on human reproduction and development. The authors hope that toxicologists, pharmacologists, medical practitioners, risk assessors, and regulatory authorities are among the groups who will find this glossary helpful, in addition to chemists. In particular, the glossary should facilitate the worldwide use of chemical terminology in relation to occupational and environmental risk assessment.

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