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https://www.readbyqxmd.com/read/28539002/from-in-vivo-to-in-vitro-the-medical-device-testing-paradigm-shift
#1
Dayna Kerecman Myers, Alan M Goldberg, Albrecht Poth, Michael F Wolf, Joseph Carraway, James McKim, Kelly P Coleman, Richard Hutchinson, Ronald Brown, Harald F Krug, Anthony Bahinski, Thomas Hartung
Amid growing efforts to advance the replacement, reduction, and refinement of the use of animals in research, there is a growing recognition that in vitro testing of medical devices can be more effective, both in terms of cost and time, and also more reliable than in vivo testing. Although the technological landscape has evolved rapidly in support of these concepts, regulatory acceptance of alternative testing methods has not kept pace. Despite the acceptance by regulators of some in vitro tests (cytotoxicity, gene toxicity, and some hemocompatibility assays), many toxicity tests still rely on animals (irritation, sensitization, acute toxicity, reproductive/developmental toxicity), even where other industrial sectors have already abandoned them...
May 25, 2017: ALTEX
https://www.readbyqxmd.com/read/28470333/extracorporeal-perfusion-of-isolated-organs-of-large-animals-bridging-the-gap-between-in-vitro-and-in-vivo-studies
#2
Carola R Daniel, Raphael Labens, David Argyle, Theresia F Licka
Since the early 20th century extracorporeal perfusion of large animal organs has been used to investigate a broad variety of research questions, thereby overcoming common draw backs of in vitro studies without suffering from ethical concerns associated with live animal research. The technique is in accordance with the 3R principles and represents an excellent opportunity to investigate in detail the physiology of organs under standardised conditions. It is also suitable for the translation of basic pre-clinical research into a more relevant arena prior to or avoiding altogether live animal research...
May 3, 2017: ALTEX
https://www.readbyqxmd.com/read/28403479/the-gard-platform-for-potency-assessment-of-skin-sensitizing-chemicals
#3
Kathrin S Zeller, Andy Forreryd, Tim Lindberg, Robin Gradin, Aakash Chawade, Malin Lindstedt
Contact allergy induced by certain chemicals is a common health concern, and several alternative methods have been developed to fulfill the requirements of European legislation with regard to hazard assessment of potential skin sensitizers. However, validated methods, which provide information about the potency of skin sensitizers, are still lacking. The cell-based assay Genomic Allergen Rapid Detection (GARD), targeting key event 3, dendritic cell activation, of the skin sensitizer AOP, uses gene expression profiling and a machine learning approach for the prediction of chemicals as sensitizers or non-sensitizers...
April 12, 2017: ALTEX
https://www.readbyqxmd.com/read/28403478/non-animal-approaches-for-toxicokinetics-in-risk-evaluations-of-food-chemicals
#4
Ans Punt, Ad A C M Peijnenburg, Ron L A P Hoogenboom, Hans Bouwmeester
The objective of the present work was to review the availability and predictive value of non-animal toxicokinetic approaches and to evaluate their current use in European risk evaluations of food contaminants, additives and food contact materials, as well as pesticides and medicines. Results revealed little use of quantitative animal or human kinetic data in risk evaluations of food chemicals, compared with pesticides and medicines. Risk evaluations of medicines provided sufficient in vivo kinetic data from different species to evaluate the predictive value of animal kinetic data for humans...
April 12, 2017: ALTEX
https://www.readbyqxmd.com/read/28301666/adaptation-of-the-keratinosens%C3%A2-skin-sensitisation-test-to-animal-product-free-cell-culture
#5
Nathalie Belot, Bushra Sim, Christopher Longmore Longmore, Lottie Roscoe, Carol Treasure
Skin sensitisation is the process by which a substance leads to an allergic reaction following skin contact. The process has been described as an adverse outcome pathway (AOP), including several key events, from skin penetration and covalent protein binding, to keratinocyte activation, dendritic cell activation and T-lymphocyte proliferation. The in vitro assay KeratinoSens™ measures the activation of keratinocytes. It is fully accepted at a regulatory level (OECD TG 442d) and appropriate for compliance with a range of legislation including the EU Cosmetics Regulation, REACH, and the CLP Regulation...
March 16, 2017: ALTEX
https://www.readbyqxmd.com/read/28230889/quantification-of-the-borderline-range-and-implications-for-evaluating-non-animal-testing-methods-precision
#6
Maria Leontaridou, Daniel Urbisch, Susanne N Kolle, Katharina Ott, Denis S Mulliner, Silke Gabbert, Robert Landsiedel
Testing methods to assess the skin sensitisation potential of a substance usually use threshold criteria to dichotomise continuous experimental read-outs into yes/no conclusions. The threshold criteria are prescribed in the respective OECD test guidelines and the conclusion is used for regulatory hazard assessment, i.e. classification and labelling of the substance. We can identify a borderline range (BR) around the classification threshold within which test results are non-conclusive due to a testing method's biological and technical variability...
February 23, 2017: ALTEX
https://www.readbyqxmd.com/read/28214915/evaluation-of-the-gard-assay-in-a-blind-cosmetics-europe-study
#7
Henrik Johansson, Robin Gradin, Andy Forreryd, Maria Agemark, Kathrin Zeller, Angelica Johansson, Olivia Larne, Erwin van Vliet, Carl Borrebaeck, Malin Lindstedt
Chemical hypersensitivity is an immunological response towards foreign substances, commonly referred to as sensitizers, which gives rise primarily to the clinical symptoms known as allergic contact dermatitis. For the purpose of mitigating risks associated with consumer products, chemicals are screened for sensitizing effects. Historically, such predictive screenings have been performed using animal models. However, due to industrial and regulatory demand, animal models for the purpose of sensitization assessment are being replaced by animal-free testing methods, a global trend that is spreading across industries and market segments...
February 17, 2017: ALTEX
https://www.readbyqxmd.com/read/28214916/facial-expression-an-under-utilised-tool-for-the-assessment-of-welfare-in-mammals
#8
Kris A Descovich, Jennifer Wathan, Matthew C Leach, Hannah M Buchanan-Smith, Paul Flecknell, David Farningham, Sarah-Jane Vick
Animal welfare is a key issue for industries that use or impact upon animals. The accurate identification of welfare states is particularly relevant to the field of bioscience, where the 3Rs framework encourages refinement of experimental procedures involving animal models. The assessment and improvement of welfare states in animals is reliant on reliable and valid measurement tools. Behavioural measures (activity, attention, posture and vocalisation) are frequently used because they are immediate and non-invasive, however no single indicator can yield a complete picture of the internal state of an animal...
February 8, 2017: ALTEX
https://www.readbyqxmd.com/read/28088129/in-vitro-eye-irritation-testing-using-the-open-source-reconstructed-hemicornea-a-ring-trial
#9
Karsten R Mewes, Maria Engelke, Michaela Zorn-Kruppa, Melinda Bartok, Rashmi Tandon, Johanna M Brandner, Dirk Petersohn
Aim of the present ring trial was to prove whether two new methodological approaches for the in vitro classification of eye irritating chemicals can be reliably transferred from the developers' laboratories to other sites.Both test methods are based on the well-established open source reconstructed 3D hemicornea models. In the first approach, the initial depth of injury in the hemicornea model after chemical treatment is derived from the quantitative analysis of histological sections. In the second approach tissue viability, as a measure for corneal damage after chemical treatment, is analyzed separately for epithelium and stroma of the hemicornea model...
January 14, 2017: ALTEX
https://www.readbyqxmd.com/read/28073113/in-vitro-to-in-vivo-extrapolation-for-drug-induced-liver-injury-using-a-pair-ranking-method
#10
Zhichao Liu, Hong Fang, Jürgen Borlak, Ruth Roberts, Weida Tong
Preclinical animal toxicity studies may not accurately predict human toxicity. In light of this, in vitro systems have been developed that have the potential to supplement or even replace animal use. We examined in vitro to in vivo extrapolation (IVIVE) of gene expression data obtained from The Open Japanese Toxicogenomics Project-Genomics Assisted Toxicity Evaluation System (Open TG-GATEs) for 131 compounds given to rats for 28 days, and to human or rat hepatocytes for 24 hours. Notably, a Pair Ranking (PRank) method was developed to assess IVIVE potential with a PRank score based on the preservation of the order of similarity rankings of compound pairs between the platforms using a receiver operating characteristic (ROC) curve analysis to measure area under the curve (AUC)...
January 11, 2017: ALTEX
https://www.readbyqxmd.com/read/28407175/oecd-efsa-workshop-on-developmental-neurotoxicity-dnt-the-use-of-non-animal-test-methods-for-regulatory-purposes
#11
Ellen Fritsche, Kevin M Crofton, Antonio F Hernandez, Susanne Hougaard Bennekou, Marcel Leist, Anna Bal-Price, Elissa Reaves, Martin F Wilks, Andrea Terron, Roland Solecki, Anne Gourmelon
No abstract text is available yet for this article.
2017: ALTEX
https://www.readbyqxmd.com/read/28407174/opinion-versus-evidence-for-the-need-to-move-away-from-animal-testing
#12
Thomas Hartung
Science is based on facts and their discourse. Willingly or unwillingly, facts are mixed with opinion, i.e., views or judgments formed, not necessarily based on fact or knowledge. This is often necessary, where we have controversial facts or no definitive evidence yet, because we need to take decisions or have to prioritize. Evidence-based approaches aim at identifying the facts and their quality objectively and transparently; they are now increasingly embraced in toxicology, especially by employing systematic reviews, meta-analyses, quality scoring, risk-of-bias tools, etc...
2017: ALTEX
https://www.readbyqxmd.com/read/28407173/corrigendum-to-the-need-for-strategic-development-of-safety-sciences
#13
Francois Busquet, Thomas Hartung
No abstract text is available yet for this article.
2017: ALTEX
https://www.readbyqxmd.com/read/28105479/from-cells-to-qsar-alternative-predictive-models-in-toxicology
#14
Yula Sambuy, Anna Maria Bassi, Chiara Scanarotti, Francesca Caloni
No abstract text is available yet for this article.
2017: ALTEX
https://www.readbyqxmd.com/read/28105478/the-need-for-strategic-development-of-safety-sciences
#15
Francois Busquet, Thomas Hartung
The practice of risk assessment and regulation of substances has largely developed as a patchwork of circumstantial additions to a nowadays more or less shared international toolbox. The dominant drivers from the US and Europe have pursued remarkably different approaches in the use of these tools for regulation, i.e., a more risk-based approach in the US and a more precautionary approach in Europe. We argue that there is need for scientific developments not only for the tools but also for their application, i...
2017: ALTEX
https://www.readbyqxmd.com/read/27725989/behavior-of-laboratory-dogs-before-and-after-rehoming-in-private-homes
#16
Dorothea Döring, Ophelia Nick, Alexander Bauer, Helmut Küchenhoff, Michael H Erhard
Although the rehoming of laboratory dogs has gained popularity, a scientific evaluation of the process is lacking. The behavior of 145 laboratory beagles was tested before leaving a research facility (Test 1). The new owners were then surveyed using a standardized telephone interview 1 week (n = 143) and 12 weeks (n = 126) after adoption. The behavior test was repeated with 68 dogs in their new homes 6 weeks after adoption (Test 2). The predictive power of Test 1 or Interview 1 on Test 2 or Interview 2, respectively, as well as the relevance of various factors was analyzed...
2017: ALTEX
https://www.readbyqxmd.com/read/27667476/replacing-reducing-and-refining-the-use-of-animals-in-tuberculosis-vaccine-research
#17
Rachel Tanner, Helen McShane
Tuberculosis (TB) remains a serious global health threat and an improved vaccine is urgently needed. New candidate TB vaccines are tested using preclinical animal models such as mice, guinea pigs, cattle and non-human primates. Animals are routinely infected with virulent Mycobacterium tuberculosis (Mtb) in challenge experiments to evaluate protective efficacy, raising ethical issues regarding the procedure of infection itself, symptoms of disease and humane end-points. We summarize the importance and limitations of animal models in TB vaccine research and review current alternatives and modifications in the context of the NC3Rs framework for replacing, reducing and refining the use of animals for scientific purposes...
2017: ALTEX
https://www.readbyqxmd.com/read/27554434/good-cell-culture-practice-for-stem-cells-and-stem-cell-derived-models
#18
David Pamies, Anna Bal-Price, Anton Simeonov, Danilo Tagle, Dave Allen, David Gerhold, Dezhong Yin, Francesca Pistollato, Takashi Inutsuka, Kristie Sullivan, Glyn Stacey, Harry Salem, Marcel Leist, Mardas Daneshian, Mohan C Vemuri, Richard McFarland, Sandra Coecke, Suzanne C Fitzpatrick, Uma Lakshmipathy, Amanda Mack, Wen Bo Wang, Daiju Yamazaki, Yuko Sekino, Yasunari Kanda, Lena Smirnova, Thomas Hartung
The first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times...
2017: ALTEX
https://www.readbyqxmd.com/read/27463612/design-of-a-high-throughput-human-neural-crest-cell-migration-assay-to-indicate-potential-developmental-toxicants
#19
Johanna Nyffeler, Christiaan Karreman, Heidrun Leisner, Yong Jun Kim, Gabsang Lee, Tanja Waldmann, Marcel Leist
Migration of neural crest cells (NCCs) is one of the pivotal processes of human fetal development. Malformations arise if NCC migration and differentiation are impaired genetically or by toxicants. In the currently available test systems for migration inhibition of NCC (MINC), the manual generation of a cell-free space results in extreme operator dependencies, and limits throughput. Here a new test format was established. The assay avoids scratching by plating cells around a commercially available circular stopper...
2017: ALTEX
https://www.readbyqxmd.com/read/27452664/reference-compounds-for-alternative-test-methods-to-indicate-developmental-neurotoxicity-dnt-potential-of-chemicals-example-lists-and-criteria-for-their-selection-and-use
#20
Michael Aschner, Sandra Ceccatelli, Mardas Daneshian, Ellen Fritsche, Nina Hasiwa, Thomas Hartung, Helena T Hogberg, Marcel Leist, Abby Li, William R Mundi, Stephanie Padilla, Aldert H Piersma, Anna Bal-Price, Andrea Seiler, Remco H Westerink, Bastian Zimmer, Pamela J Lein
There is a paucity of information concerning the developmental neurotoxicity (DNT) hazard posed by industrial and environmental chemicals. New testing approaches will most likely be based on batteries of alternative and complementary (non-animal) tests. As DNT is assumed to result from the modulation of fundamental neurodevelopmental processes (such as neuronal differentiation, precursor cell migration or neuronal network formation) by chemicals, the first generation of alternative DNT tests target these processes...
2017: ALTEX
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