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    RPTEC/TERT1 cells form highly differentiated tubules when cultured in a 3D matrix.
    ALTEX 2017 Dec 2. Epub 2017 Dec 2.
    Human and Environmental Toxicology, Department of Biology, University of Konstanz, Konstanz, Germany.
    The proximal tubule is the primary site for renal solute reabsorption and secretion and thus a main target for drug-induced toxicity. Current nonclinical methods using 2D cell cultures are unable to fully recapitulate clinical drug responses mainly due to limited in vitro functional lifespan. Since extracellular matrices are known to be key regulators of cell development, culturing cells on classic 2D plastic surfaces inevitably results in loss of differentiation. Read More

    Recommendations to improve the EU non-technical summaries of animal experiments.
    ALTEX 2017 Nov 29. Epub 2017 Nov 29.
    Animal Welfare Academy, German Animal Welfare Federation, Neubiberg, Germany.
    Under the new Directive 2010/63/EC, member states have to publish non-technical summaries (NTS) of the projects involving animals that they authorise. These summaries must include information on the objectives of the project including the predicted harm and benefits and the number and types of animals to be used. Summaries should also demonstrate compliance with the 3Rs. Read More

    Co-culture of human alveolar epithelial (hAELVi) and macrophage (THP-1) cell lines.
    ALTEX 2017 23;34(4). Epub 2017 Nov 23.
    Department Drug Delivery (DDEL), Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), Saarland University, Saarbrücken, Germany.
    The air-blood barrier is mainly composed of alveolar epithelial cells and macrophages. Whereas the epithelium acts as a diffusional barrier, macrophages represent an immunological barrier, in particular for larger molecules and nanoparticles. This paper describes a new co-culture of human cell lines representing both cell types. Read More

    The GARD platform for potency assessment of skin sensitizing chemicals.
    ALTEX 2017 12;34(4):539-559. Epub 2017 Apr 12.
    Department of Immunotechnology, Medicon Village, Lund, Sweden.
    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 sensitization AOP, uses gene expression profiling and a machine learning approach for the prediction of chemicals as sensitizers or non-sensitizers. Read More

    Computational approaches to chemical hazard assessment.
    ALTEX 2017 ;34(4):459-478
    Johns Hopkins Center for Alternatives to Animal Testing (CAAT), Baltimore, MD, USA.
    Computational prediction of toxicity has reached new heights as a result of decades of growth in the magnitude and diversity of biological data. Public packages for statistics and machine learning make model creation faster. New theory in machine learning and cheminformatics enables integration of chemical structure, toxicogenomics, simulated and physical data in the prediction of chemical health hazards, and other toxicological information. Read More

    State-of-the-art and new options to assess T cell activation by skin sensitizers: Cosmetics Europe Workshop.
    ALTEX 2017 Oct 2. Epub 2017 Oct 2.
    Henkel AG & Co. KGaA, Düsseldorf, Germany.
    Significant progress has been made in the development and validation of non-animal test methods for skin sensitization assessment. At present, three of the four key events of the Adverse Outcome Pathway (AOP) are assessable by OECD-accepted in vitro methods. The fourth key event describes the immunological response in the draining lymph node where activated dendritic cells present major histocompatibility complex-bound chemically modified peptides to naive T cells, thereby priming the proliferation of antigen-specific T cells. Read More

    Integrated strategy for mutagenicity prediction applied to food contact chemicals.
    ALTEX 2017 Sep 18. Epub 2017 Sep 18.
    Chemical Food Safety Group, Nestlé Research Center, Lausanne, Switzerland.
    Food contamination due to unintentional leakage of chemicals from food contact materials (FCM) is a source of increasing concern. Since for many of these substances, only limited or no toxicological data are available, the development of alternative methodologies to establish rapidly and cost-efficiently level of safety concern is critical to ensure adequate consumer protection. Computational toxicology methods are considered the most promising solutions to cope with this data gap. Read More

    Ex vivo model unravelling cell distribution effect in hydrogels for cartilage repair.
    ALTEX 2017 Sep 8. Epub 2017 Sep 8.
    Department of Oral and Maxillofacial Surgery & Special Dental Care, University Medical Center Utrecht, Utrecht, The Netherlands.
    The implantation of chondrocyte-laden hydrogels is a promising cartilage repair strategy. Chondrocytes can be spatially positioned in hydrogels and thus in defects, while current clinical cell-therapies introduce chondrocytes in the defect depth. The main aim of this study was to evaluate the effect of spatial chondrocyte distribution on the reparative process. Read More

    Prediction of acute inhalation toxicity using in vitro lung surfactant inhibition.
    ALTEX 2017 Aug 17. Epub 2017 Aug 17.
    The National Research Centre for the Working Environment, Copenhagen, Denmark.
    Private consumers and professionals may experience acute inhalation toxicity after inhaling aerosolized impregnation products. The distinction between toxic and non-toxic products is difficult to make for producers and product users alike, as there is no clearly described relationship between the chemical composition of the products and induction of toxicity. The currently accepted method for determination of acute inhalation toxicity is based on experiments on animals; it is time-consuming, expensive and causes stress for the animals. Read More

    Fetal Bovine Serum (FBS): Past - Present - Future.
    ALTEX 2017 Aug 9. Epub 2017 Aug 9.
    Division of Physiology, Medical University Innsbruck, Innsbruck, Austria.
    The supplementation of culture medium with fetal bovine serum (FBS, also referred to as 'fetal calf serum') is still common practice in cell culture applications. Due to a number of disadvantages in terms of quality and reproducibility of in vitro data, animal welfare concerns, and in light of recent cases of fraudulent marketing, the search for alternatives and the development of serum-free medium formulations gained global attention. Here, we report on the 3rd Workshop on FBS, Serum Alternatives and Serum-free Media, where (a) regulatory aspects, (b) the serum dilemma, (c) alternatives to FBS, (d) case-studies of serum-free in vitro applications, and (e) the establishment of serum-free databases, were discussed. Read More

    Use of high-throughput in vitro toxicity screening data in cancer hazard evaluations by IARC Monograph Working Groups.
    ALTEX 2017 Jul 24. Epub 2017 Jul 24.
    Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, TX, USA.
    Evidence regarding carcinogenic mechanisms serves a critical role in International Agency for Research on Cancer (IARC) Monograph evaluations. Three recent IARC Working Groups pioneered inclusion of the US Environmental Protection Agency (EPA) ToxCast program high-throughput screening (HTS) data to supplement other mechanistic evidence. In Monograph V110, HTS profiles were compared between perfluorooctanoic acid (PFOA) and prototypical activators across multiple nuclear receptors. Read More

    Thresholds of Toxicological Concern - Setting a threshold for testing below which there is little concern.
    ALTEX 2017 ;34(3):331-351
    Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
    Low dose, low risk; very low dose, no real risk. Setting a pragmatic threshold below which concerns become negligible is the purpose of thresholds of toxicological concern (TTC). The idea is that such threshold values do not need to be established for each and every chemical based on experimental data, but that by analyzing the distribution of lowest or no-effect doses of many chemicals, a TTC can be defined - typically using the 5th percentile of this distribution and lowering it by an uncertainty factor of, e. Read More

    A validated algorithm for selecting non-toxic chemical concentrations.
    ALTEX 2017 Jun 26. Epub 2017 Jun 26.
    EPF Lausanne, School of Architecture, Civil and Environmental Engineering, Lausanne, Switzerland.
    The maximal chemical concentration that causes an acceptably small or no effect in an organism or isolated cells is an often-sought-after value in toxicology. Existing approaches to derive this value have raised several concerns; thus, it is often chosen case-by-case based on personal experience. To overcome this ambiguity, we propose an approach for choosing the non-toxic concentration (NtC) of a chemical in a rational, tractable way. Read More

    From in vivo to in vitro: The medical device testing paradigm shift.
    ALTEX 2017 25;34(4):479-500. Epub 2017 May 25.
    Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
    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. Read More

    Extracorporeal perfusion of isolated organs of large animals - Bridging the gap between in vitro and in vivo studies.
    ALTEX 2017 May 3. Epub 2017 May 3.
    Division of Veterinary Clinical Sciences, Royal (Dick) School of Veterinary Studies and The Roslin Institute, Easter Bush Campus, Midlothian, UK.
    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. Read More

    Adaptation of the KeratinoSens™ skin sensitization test to animal-product-free cell culture
    ALTEX 2017 12;34(4):560-564. Epub 2017 Apr 12.
    XCellR8 Ltd, The Innovation Centre, Sci-Tech Daresbury, Daresbury, Cheshire, UK.
    Skin sensitization is the process by which a substance induces 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. Read More

    Non-animal approaches for toxicokinetics in risk evaluations of food chemicals.
    ALTEX 2017 12;34(4):501-514. Epub 2017 Apr 12.
    RIKILT Wageningen University and Research, Wageningen, the Netherlands.
    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. Read More

    The borderline range of toxicological methods: Quantification and implications for evaluating precision.
    ALTEX 2017 23;34(4):525-538. Epub 2017 Feb 23.
    BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
    Test methods to assess the skin sensitization potential of a substance usually use threshold criteria to dichotomize 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. Read More

    Facial expression: An under-utilised tool for the assessment of welfare in mammals.
    ALTEX 2017 8;34(3):409-429. Epub 2017 Feb 8.
    Psychology, Faculty of Natural Sciences, University of Stirling, Stirling, United Kingdom.
    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 depends on reliable and valid measurement tools. Read More

    Evaluation of the GARD assay in a blind Cosmetics Europe study.
    ALTEX 2017 17;34(4):515-523. Epub 2017 Feb 17.
    Dept. of Immunotechnology, Lund University, Lund, Sweden.
    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. Read More

    The need for strategic development of safety sciences.
    ALTEX 2017 ;34(1):3-21
    Center for Alternatives to Animal Testing, CAAT-Europe, University of Konstanz, Konstanz, Germany.
    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. Read More

    In vitro eye irritation testing using the open source reconstructed hemicornea - a ring trial.
    ALTEX 2017 14;34(3):430-434. Epub 2017 Jan 14.
    Henkel AG & Co. KGaA; Düsseldorf, Germany.
    The aim of the present ring trial was to test 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 after chemical treatment in the hemicornea model is derived from the quantitative analysis of histological sections. Read More

    In vitro to in vivo extrapolation for drug-induced liver injury using a pair ranking method.
    ALTEX 2017 11;34(3):399-407. Epub 2017 Jan 11.
    National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, USA.
    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. Read More

    Incorporation of a metabolizing system in biodetection assays for endocrine active substances.
    ALTEX 2016 Dec 22. Epub 2016 Dec 22.
    Chemical Food Safety, Nestlé Research Centre, Lausanne, Switzerland.
    The use of in vitro assays is important for the biodetection of endocrine active substances (EAS), reducing and replacing the in vivo studies required for regulatory assessment. However, this approach often fails to take into account the role of biotransformation on the activity of the test substances. A method incorporating an S9 metabolic system into the CALUX-reporter gene assays for estrogen receptor α- and anti-androgen receptor -mediated activities has been developed. Read More

    A tiered, Bayesian approach to estimating of population variability for regulatory decision-making.
    ALTEX 2017 13;34(3):377-388. Epub 2016 Dec 13.
    Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, TX, USA.
    Characterizing human variability in susceptibility to chemical toxicity is a critical issue in regulatory decision-making, but is usually addressed by a default 10-fold safety/uncertainty factor. Feasibility of population-based in vitro experimental approaches to more accurately estimate human variability was demonstrated recently using a large (~1000) panel of lymphoblastoid cell lines. However, routine use of such a large population-based model poses cost and logistical challenges. Read More

    A human brain microphysiological system derived from induced pluripotent stem cells to study neurological diseases and toxicity.
    ALTEX 2017 24;34(3):362-376. Epub 2016 Nov 24.
    Center for Alternatives to Animal Testing, Johns Hopkins University, Baltimore, USA.
    Human in vitro models of brain neurophysiology are needed to investigate molecular and cellular mechanisms associated with neurological disorders and neurotoxicity. We have developed a reproducible iPSC-derived human 3D brain microphysiological system (BMPS), comprised of differentiated mature neurons and glial cells (astrocytes and oligodendrocytes) that reproduce neuronal-glial interactions and connectivity. BMPS mature over eight weeks and show the critical elements of neuronal function: synaptogenesis and neuron-to-neuron (e. Read More

    Systems biology for organotypic cell cultures.
    ALTEX 2017 14;34(2):301-310. Epub 2016 Nov 14.
    The Hamner Institutes for Health Sciences, Research Triangle Park, NC, USA.
    Translating in vitro biological data into actionable information related to human health holds the potential to improve disease treatment and risk assessment of chemical exposures. While genomics has identified regulatory pathways at the cellular level, translation to the organism level requires a multiscale approach accounting for intra-cellular regulation, inter-cellular interaction, and tissue/organ-level effects. Tissue-level effects can now be probed in vitro thanks to recently developed systems of three-dimensional (3D), multicellular, "organotypic" cell cultures, which mimic functional responses of living tissue. Read More

    Alternative acute oral toxicity assessment under REACH based on sub-acute toxicity values.
    ALTEX 2017 8;34(3):353-361. Epub 2016 Nov 8.
    European Chemicals Agency (ECHA), Helsinki, Finland.
    The REACH Regulation requires information on acute oral toxicity for substances produced or imported in quantities greater than one ton per year. When registering, animal testing should be used as last resort. The standard acute oral toxicity test requires use of animals. Read More

    Advancing toxicology research using in vivo high throughput toxicology with small fish models.
    ALTEX 2016 21;33(4):435-452. Epub 2016 Jun 21.
    Integrated Laboratory Systems, Inc., Research Triangle Park, NC, USA.
    Small freshwater fish models, especially zebrafish, offer advantages over traditional rodent models, including low maintenance and husbandry costs, high fecundity, genetic diversity, physiology similar to that of traditional biomedical models, and reduced animal welfare concerns. The Collaborative Workshop on Aquatic Models and 21st Century Toxicology was held at North Carolina State University on May 5-6, 2014, in Raleigh, North Carolina, USA. Participants discussed the ways in which small fish are being used as models to screen toxicants and understand mechanisms of toxicity. Read More

    Bridging the gap between regulatory acceptance and industry use of non-animal methods.
    ALTEX 2016 2;33(4):453-458. Epub 2016 Jun 2.
    People for the Ethical Treatment of Animals, Norfolk, VA, USA.
    Collaboration between industry and regulators resulted in the development of a decision tree approach using in vitro or ex vivo assays to replace animal tests when determining the eye irritation potential of antimicrobial cleaning products (AMCPs) under the United States Environmental Protection Agency (EPA) Office of Pesticide Programs' hazard classification and labeling system. A policy document issued by the EPA in 2013 and updated in 2015 describes the alternate testing framework that industry could apply to new registrations of AMCPs and, on a case-by-case basis, to conventional pesticide products. Despite the collaborative effort, the availability of relevant non-animal methods, and the EPA's change in policy, only a limited number of AMCPs have been registered using the framework. Read More

    MUTZ-3 Langerhans cell maturation and CXCL12 independent migration in reconstructed human gingiva.
    ALTEX 2016 19;33(4):423-434. Epub 2016 May 19.
    Department of Dermatology, VU University Medical Center, Amsterdam, the Netherlands.
    Here we describe a reconstructed full thickness human oral mucosa (gingiva) equivalent with integrated Langerhans Cells (GE-LC) and use it to compare LC activation and migration from oral versus skin epithelium. The physiologically representative models consist of differentiated reconstructed epithelium (keratinocytes and Langerhans-like cells derived from the MUTZ-3 cell line) on a fibroblast-populated collagen hydrogel which serves as a lamina propria for gingiva and dermis for skin. Topical exposure of GE-LC and the skin equivalent (SE-LC) to sub-toxic concentrations of the allergens cinnamaldehyde, resorcinol and nickel sulphate, resulted in LC migration out of the epithelia. Read More

    A first vascularized skin equivalent as an alternative to animal experimentation.
    ALTEX 2016 15;33(4):415-422. Epub 2016 May 15.
    Translational Center Würzburg, Fraunhofer Institute for Interfacial Engineering and Biotechnology (IGB) Würzburg, Germany.
    Tissue-engineered skin equivalents mimic key aspects of the human skin, and can thus be employed as wound coverage for large skin defects or as in vitro test systems as an alternative to animal models. However, current skin equivalents lack a functional vasculature limiting clinical and research applications. This study demonstrates the generation of a vascularized skin equivalent with a perfused vascular network by combining a biological vascularized scaffold (BioVaSc) based on a decellularized segment of a porcine jejunum and a tailored bioreactor system. Read More

    Organotypic retinal explant cultures as in vitro alternative for diabetic retinopathy studies.
    ALTEX 2016 9;33(4):459-464. Epub 2016 May 9.
    Centro Interdisciplinario de Neurociencia de Valparaíso, Universidad de Valparaíso, Chile.
    Diabetic retinopathy (DR) is a major cause of vision loss and one of the most common and debilitating complications of diabetes. Research to prevent DR is hindered by a lack of experimental model systems that faithfully reproduce the disease pathology, in particular for type 2 diabetes, which requires prolonged disease progression in animals to develop some hallmarks of DR. Here, we introduce an alternative in vitro model system for DR, based on serum-free, organotypic rodent retinal explant cultures, which allow physiological and pharmacological manipulation of the retina for up to two weeks under tightly controlled conditions. Read More

    Ex vivo assessment of testicular toxicity induced by carbendazim and iprodione, alone or in a mixture.
    ALTEX 2016 8;33(4):393-413. Epub 2016 May 8.
    CEA, Direction de la Recherche Fondamentale, BIAM-Marcoule, Bagnols-sur-Cèze, France.
    To measure the testicular toxicity of two fungicides (carbendazim and iprodione), alone or in a mixture, we used a rat ex vivo model of seminiferous tubules, greatly reducing the number of rodents used, in accordance with the 3R rule (Replacement, Reduction, and Refinement). This model allows the representation of puberty, a critical life period with regard to endocrine disruptors. The cellular modifications were followed for three weeks through transcriptomic and proteomic profiling analysis. Read More

    International regulatory needs for development of an IATA for non-genotoxic carcinogenic chemical substances.
    ALTEX 2016 27;33(4):359-392. Epub 2016 Apr 27.
    CNRS UMR 7360, University of Lorraine, Metz, France.
    Although regulatory requirements for carcinogenicity testing of chemicals vary according to product sector and regulatory jurisdiction, the standard approach starts with a battery of genotoxicity tests. If any of the in vivo genotoxicity tests are positive, a lifetime rodent cancer bioassay may be requested, which allows the detection of non-genotoxic carcinogens (NGTxC). However, under most chemical regulations the cancer bioassay is rarely requested, specific requests to obtain information on non-genotoxic mechanisms of carcinogenicity are few, and there are no OECD approved screening methods. Read More

    Evidence-based absorption, distribution, metabolism, excretion (ADME) and its interplay with alternative toxicity methods.
    ALTEX 2016 ;33(4):343-358
    Johns Hopkins Bloomberg School of Public Health, Center for Alternatives to Animal Testing (CAAT), Baltimore, USA.
    ADME (absorption, distribution, metabolism, elimination) has rapidly evolved over the past two decades, creating a unique interdisciplinary interface between medicinal chemists, biologists, formulators, toxicologists, clinicians, and regulators across industries, but has advanced most rapidly in the pharmaceutical industry. The implementation of ADME profiling of drug candidates, in conjunction with biological efficacy and safety optimization, has dramatically reduced pharmacokinetic drug failures in clinical trials and has become a lingua franca between disciplines that are involved in drug development. This article briefly reviews the basics and current state-of-the-art of ADME and the major lessons from the pharmaceutical industry on its efficient use, points out the importance of defining ADME properties leading to toxicity across industries for safety and toxicity prediction of chemicals, and raises the issues of quality, reliability, and reproducibility of tests and inclusion of ADME under the umbrella of evidence-based toxicology. Read More

    Uncertainties of testing methods: What do we (want to) know about carcinogenicity?
    ALTEX 2017 24;34(2):235-252. Epub 2016 Oct 24.
    Department of Toxicology, Centre for Radiation, Chemical and Environmental Hazards Public Health England, Chilton, Oxfordshire, UK.
    An approach to systematically describe the uncertainties and complexity of the standard animal testing and assessment approach for carcinogenicity is explored by using a OECD Guidance Document that was originally developed for reporting defined in vitro approaches to testing and assessment. The format is suitable for this re-purposing and it appears that the potential multitude of approaches for integrating and interpreting data from standard animal testing may ultimately be conceptually similar to the challenge of integrating relevant in vitro and in silico data. This structured approach shall allow 1) fostering interest in developing improved defined in silico and in vitro approaches; 2) the definition of what type of effects should be predicted by the new approach; 3) selection of the most suitable reference data and assessments; 4) definition of the weight that the standard animal reference data should have compared to human reference data and mechanistic information in the context of assessing the fitness of the new in vitro and in silico approach; 5) definition of a benchmark for the minimum performance of the new approach, based on a conceptual recognition that correlation of alternative assessment results with reference animal results is limited by the uncertainties and complexity of the latter. Read More

    Ex vivo culture platform for assessment of cartilage repair treatment strategies.
    ALTEX 2017 21;34(2):267-277. Epub 2016 Oct 21.
    LifeTec Group BV, Eindhoven, The Netherlands.
    There is a great need for valuable ex vivo models that allow for assessment of cartilage repair strategies to reduce the high number of animal experiments. In this paper we present three studies with our novel ex vivo osteochondral culture platform. It consists of two separated media compartments for cartilage and bone, which better represents the in vivo situation and enables supply of factors specific to the different needs of bone and cartilage. Read More

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