LATEST ISSUE

Volume 44, Issue 2 - May 2016

smoking an e-cigarette
Tracking with microbeads on a 3-D human airway epithelium

Concerns that Animal Testing Continues Without Scientific Justification

Michael Balls

Risk assessment and public health policies ought to be based on relevant and reliable scientific evidence
You need to register (for free) to download this article. Please log in/register here.

News and Views

ATLA staff

SEARCHBreast Resource Available
Canine OCD
Progress on 3-D Brain Tumour Models
In Vitro Model of B. pertussis Colonisation
Stem Cells Used to Study Chemotherapy Side-effects
You need to register (for free) to download this article. Please log in/register here.

IIVS News and Views

IIVS staff

IIVS Awarded Grant to Develop Non-animal Testing Strategy for Respiratory Sensitisation
IIVS Workshop Explores Exposure and Dosimetry Considerations for Non-animal Testing
IIVS Presents Posters at SOT 2016
IIVS to Hold Free Webinar: Regulatory Initiatives for New Approaches to Traditional Toxicity Testing

You need to register (for free) to download this article. Please log in/register here.

CAAT News and Views

CAAT staff

CAAT Team’s Read-across Database Featured in Science and Nature
SOT Satellite Meeting on 21st Century Toxicology and Related Efforts
Other CAAT Activities at the SOT Annual Meeting
CAAT’s Georgina Harris Appointed Graduate Student Representative to the IVAM Specialty Section
Symposium on Social Housing of Laboratory Animals
Pan-American Conference on Alternative Methods
Recent Publications
You need to register (for free) to download this article. Please log in/register here.

Stakeholder Views on the Creation and Use of Genetically-Engineered Animals in Research

Elisabeth H. Ormandy

This interview-based study examined the diversity of views relating to the creation and use of genetically-engineered (GE) animals in biomedical science. Twenty Canadian participants (eight researchers, five research technicians and seven members of the public) took part in the interviews, in which four main themes were discussed: a) how participants felt about the genetic engineering of animals as a practice; b) governance of the creation and use of GE animals in research, and whether current guidelines are sufficient; c) the Three Rs (Replacement, Reduction, Refinement) and how they are applied during the creation and use of GE animals in research; and d) whether public opinion should play a greater role in the creation and use of GE animals. Most of the participants felt that the creation and use of GE animals for biomedical research purposes (as opposed to food purposes) is acceptable, provided that tangible human health benefits are gained. However, obstacles to Three Rs implementation were identified, and the participants agreed that more effort should be placed on engaging the public on the use of GE animals in research.

This article is currently only available in full to paid subscribers. Click here to subscribe, or
you will need to log in/register to buy and download this article


Evaluation of an In Vitro Cell Culture Assay for the Potency Assessment of Recombinant Human Erythropoietin

Francine T. Machado, Fernanda P.S. Maldaner, Rafaela F. Perobelli, Bruna Xavier, Francielle S. da Silva, Guilherme W. de Freitas, Paolo Bartolini, Maria Tereza C.P. Ribela and Sérgio L. Dalmora

Recombinant human erythropoietin is a sialoglycoprotein that stimulates erythropoiesis. To assess potency of human erythropoietin produced by recombinant technology, we investigated an in vitro TF-1 cell proliferation assay, which was applied in conjunction with a reversed-phase liquid chromatography method for the determination of the content of sialic acids. The results obtained, which were higher than 126.8ng/μg, were compared with those obtained with the in vivo normocythaemic mouse bioassay. The in vitro assay resulted in a non-significant lower mean difference of the estimated potencies (0.61% ± 0.026, p > 0.05). The use of this combination of methods represents an advance toward the establishment of alternative in vitro approaches, in the context of the Three Rs, for the potency assessment of biotechnology-derived medicines.

This article is currently only available in full to paid subscribers. Click here to subscribe, or
you will need to log in/register to buy and download this article


The Use of a Decision Tree Based on the Rabies Diagnosis Scenario, to Assist the Implementation of Alternatives to Laboratory Animals

Vanessa Carli Bones and Carla Forte Maiolino Molento

Brazilian federal legislation makes the use of alternatives mandatory, when there are validated methods to replace the use of laboratory animals. The objective of this paper is to introduce a novel decision tree (DT)-based approach, which can be used to assist the replacement of laboratory animal procedures in Brazil. This project is based on a previous analysis of the rabies diagnosis scenario, in which we identified certain barriers that hinder replacement, such as: a) the perceived higher costs of alternative methods; b) the availability of staff qualified in these methods; c) resistance to change by laboratory staff; d) regulatory obstacles, including incompatibilities between the Federal Environmental Crimes Act and specific norms and working practices relating to the use of laboratory animals; and e) the lack of government incentives. The DT represents a highly promising means to overcome these reported barriers to the replacement of laboratory animal use in Brazil. It provides guidance to address the main obstacles, and, followed step-by-step, would lead to the implementation of validated alternative methods (VAMs), or their development when such alternatives do not exist. The DT appears suitable for application to laboratory animal use scenarios where alternative methods already exist, such as in the case of rabies diagnosis, and could contribute to increase compliance with the Three Rs principles in science and with the current legal requirements in Brazil.

This article is currently only available in full to paid subscribers. Click here to subscribe, or
you will need to log in/register to buy and download this article


Assessment of In Vitro COPD Models for Tobacco Regulatory Science: Workshop Proceedings, Conclusions and Paths Forward for In Vitro Model Use

Holger Behrsing, Hans Raabe, Joseph Manuppello, Betsy Bombick, Rodger Curren, Kristie Sullivan, Sanjay Sethi, Richard Phipps, Yohannes Tesfaigzi, Sherwin Yan, Carl D’Ruiz, Robert Tarran, Samuel Constant, Gary Phillips, Marianna Gaça, Patrick Hayden, Xuefei Cao, Carole Mathis, Julia Hoeng, Armin Braun and Erin Hill

The Family Smoking Prevention and Tobacco Control Act of 2009 established the Food and Drug Administration Center for Tobacco Products (FDA-CTP), and gave it regulatory authority over the marketing, manufacture and distribution of tobacco products, including those termed 'modified risk'. On 8-10 December 2014, IIVS organised a workshop conference, entitled Assessment of In Vitro COPD Models for Tobacco Regulatory Science, to bring together stakeholders representing regulatory agencies, academia, industry and animal protection, to address the research priorities articulated by the FDA-CTP. Specific topics were covered to assess the status of current in vitro technologies as they are applied to understanding the adverse pulmonary events resulting from tobacco product exposure, and in particular, the progression of chronic obstructive pulmonary disease (COPD). The four topics covered were: a) Inflammation and Oxidative Stress; b) Ciliary Dysfunction and Ion Transport; c) Goblet Cell Hyperplasia and Mucus Production; and d) Parenchymal/Bronchial Tissue Destruction and Remodelling. The 2.5 day workshop included 18 expert speakers, plus poster sessions, networking and breakout sessions, which identified key findings and provided recommendations to advance the in vitro technologies and assays used to evaluate tobacco-induced disease etiologies. The workshop summary was reported at the 2015 Society of Toxicology Annual Meeting, and the recommendations led to an IIVS-organised technical workshop in June 2015, entitled Goblet Cell Hyperplasia, Mucus Production, and Ciliary Beating Assays, to assess these assays and to conduct a proof-of-principle multi-laboratory exercise to determine their suitability for standardisation. Here, we report on the proceedings, recommendations and outcomes of the December 2014 workshop, including paths forward to continue the development of non-animal methods to evaluate tissue responses that model the disease processes that may lead to COPD, a major cause of mortality worldwide.

This article is currently only available in full to paid subscribers. Click here to subscribe, or
you will need to log in/register to buy and download this article


Transparency and Public Involvement in Animal Research

Pandora Pound and Ricardo Blaug

To be legitimate, research needs to be ethical, methodologically sound, of sufficient value to justify public expenditure and be transparent. Animal research has always been contested on ethical grounds, but there is now mounting evidence of poor scientific method, and growing doubts about its clinical value. So what of transparency? Here we examine the increasing focus on openness within animal research in the UK, analysing recent developments within the Home Office and within the main group representing the interests of the sector, Understanding Animal Research. We argue that, while important steps are being taken toward greater transparency, the legitimacy of animal research continues to be undermined by selective openness. We propose that openness could be increased through public involvement, and that this would bring about much needed improvements in animal research, as it has done in clinical research.

This article is currently only available in full to paid subscribers. Click here to subscribe, or
you will need to log in/register to buy and download this article


FRAME is the Fund for the Replacement of Animals in Medical Experiments. It publishes ATLA. It also promotes the replacement of animals in laboratories through better science. Visit FRAME website
PiLAS is Perspectives in Laboratory Animal Science. It improves the quality of discussion about animal experimentation by giving scientists in all fields a place to exchange views. Read PiLAS