replacement

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Barriers to the Uptake of Human-based Test Methods, and How to Overcome Them

Kathy Archibald, Tamara Drake and Robert Coleman

Although there is growing concern as to the questionable value of animal-based methods for determining the safety and efficacy of new medicines, which has in turn led to many groups developing innovative human-based methods, there are many barriers to their adoption for regulatory submissions.
The reasons for this are various, and include a lack of confidence that the available human-based methods, be they in vivo, in silico or in vitro, can be sufficiently predictive of clinical outcomes. However, this is not the only problem: the issue of validation presents a serious impediment to progress, a particularly frustrating situation, in view of the fact that the existing animal-based methods have never themselves been formally validated. Superimposed upon this is the issue of regulatory requirements, where, although regulators may be willing to accept non-animal approaches in place of particular animal tests, nowhere is this explicitly stated in their guidelines. Such problems are far from trivial, and represent major hurdles to be overcome. In addition, there are a range of other barriers, real or self-imposed, that are hindering a more-predictive approach to establishing a new drug’s clinical safety and efficacy profiles. Some of these barriers are identified, and ways forward are suggested.
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2014 Lush Science Prize – background paper

Terry McCann

The Lush Prize supports animal-free testing by rewarding the most effective projects and individuals who have been working toward the goal of replacing animals in product or ingredient safety testing. A Background Paper is prepared each year, prior to the judging process, to provide the panel with a
brief overview of current developments in the field of Replacement alternatives, particularly those relevant to the concept of toxicity pathways. This Background Paper includes information on recent work by the relevant scientific institutions and projects in this area, including AXLR8, OECD, CAAT, The Hamner Institutes, the Human Toxome Project, EURL ECVAM, ICCVAM, the US Tox21 Programme, the ToxCast programme, and the Human Toxicology Project Consortium. Recent developments in toxicity pathway research are also assessed by reviewing the relevant literature, with a view to presenting the two papers receiving the highest score to the judges for consideration.
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Humane Education in Brazil: Organisation, Challenges and Opportunities

Róber Bachinski, Thales Tréz, Gutemberg G. Alves, Rita de C.M. Garcia, Simone T. Oliveira, Luciano da S. Alonso, Júlio X. Heck, Claudia M.C. Dias, João M. Costa Neto, Alexandro A. Rocha, Valeska R.R. Ruiz and Rita L. Paixão

Humane education and the debate on alternatives to harmful animal use for training is a relatively recent issue in Brazil. While animal use in secondary education has been illegal since the late 1970s, animal use in higher science education is widespread. However, alternatives to animal experiments in research and testing have recently received attention from the Government, especially after the first legislation on animal experiments was passed, in 2008. This article proposes that higher science education should be based on a critical and humane approach. It outlines the recent establishment of the Brazilian Network for Humane Education (RedEH), as a result of the project, Mapping Animal Use for Undergraduate Education in Brazil, which was recognised by the 2014 Lush Prize. The network aims to create a platform to promote change in science education in Brazil, starting by quantitatively and qualitatively understanding animal use, developing new approaches adapted to the current needs in Brazil and Latin America, and communicating these initiatives nationally. This paper explores the trajectory of alternatives and replacement methods to harmful animal use in training and education, as well as the status of humane education in Brazil, from the point of view of educators and researchers engaged with the network.
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Comparative Costs of the Mouse Inoculation Test (MIT) and Virus Isolation in Cell Culture (VICC) for Use in Rabies Diagnosis in Brazil

Vanessa C. Bones, Augusto H. Gameiro, Juliana G. Castilho and Carla F.M. Molento

The decision to use laboratory animals rather than in vitro methods is frequently based on the financial costs involved, so the objective of our study was to compare the costs of performing the Mouse Inoculation Test (MIT) and Virus Isolation in Cell Culture (VICC) for use in rabies diagnosis in Brazil. Based on observations of laboratory routines at the Pasteur Institute, São Paulo, we listed the fixed cost (FC) and variable cost (VC) items necessary to perform both tests. Considering that 200 MITs are equivalent to 350 VICC assays, in terms of facilities and staff-hours needed per month, we calculated, for both tests, the average total cost per sample, the costs of the implementation of the laboratory structure, and the costs of routine use. With regard to absolute values, the total cost was mainly influenced by FC items, as they represented 60% of the cost for the MIT and 86% of the cost for VICC. A sample analysed by the MIT costs around 205% more than one analysed by using VICC. The MIT costs 74% and 406% more than VICC, when implementation costs and routine use per month, respectively, are taken into account. Our results can assist in the resolution of costing disputes that could hinder the replacement of animals for rabies diagnosis in Brazil. The method demonstrated here might also be useful for cost comparisons in other situations where animal use still continues when validated alternatives exist.
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2013 Lush Science Prize Background Paper

Rob Harrison

The annual Lush Science Prize is designed to reward outstanding contributions to 21st Century Toxicology Research. A Background Paper is prepared each year prior to the judging process, in order to provide the judging panel with a brief overview of current developments in the field of Replacement alternatives, particularly those relevant to the concept of toxicity pathways. The Background Paper includes information on some key institutional developments in the area — such as the OECD’s Adverse Outcome Pathway Project, the Hamner Institute’s work, and the Human Toxome Project, and on the phenomenon of collaborative computer systems relevant to the field. From the literature review that was also performed as part of the background research, the two papers receiving the highest score were recommended for consideration by the judges for the 2013 Science Prize.
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