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https://www.readbyqxmd.com/read/30015985/investigating-cell-type-specific-mechanisms-contributing-to-acute-oral-toxicity
#1
Pilar Prieto, Rabea Graepel, Kirsten Gerloff, Lara Lamon, Magdalini Sachana, Francesca Pistollato, Laura Gribaldo, Anna Bal-Price, Andrew Worth
The replacement of animals in acute systemic toxicity testing remains a considerable challenge. Only animal data are currently accepted by regulators, including data generated by reduction and refinement methods. The development of Integrated Approaches to Testing and Assessment (IATA) is hampered by an insufficient understanding of the numerous toxicity pathways that lead to acute systemic toxicity. Therefore, central to our work has been the collection and evaluation of the mechanistic information on eight organs identified as relevant for acute systemic toxicity (nervous system, cardiovascular system, liver, kidney, lung, blood, gastrointestinal system and immune system)...
July 12, 2018: ALTEX
https://www.readbyqxmd.com/read/30015984/replacement-of-foot-and-mouth-disease-virus-cattle-tongue-titration-by-in-vitro-titration
#2
Aldo Dekker, Froukje Van Hemert-Kluitenberg, Anna H Oosterbaan, Kimberly Moonen, Laure Mouton
Titration of foot-and-mouth disease cattle challenge virus in cattle tongue has been the standard for many years in many countries, although for all other applications titration in animals has be replaced by in vitro methods. The objective of the analysis was the replacement of in vivo titration of cattle challenge virus by in vitro titration. Using data from 32 in vivo titration experiments together with the in vitro titration results, obtained by plaque count on primary lamb or pig kidney cells, of the same samples, as well as data from the virus isolation control chart used in the laboratory, we show that the repeatability of the in vitro titration is much higher than the repeatability of the in vivo titration...
July 12, 2018: ALTEX
https://www.readbyqxmd.com/read/29999169/reevaluating-the-role-of-megalin-in-renal-vitamin-d-homeostasis-using-a-human-cell-derived-microphysiological-system
#3
Brian D Chapron, Alenka Chapron, Brian Phillips, Miracle C Okoli, Danny D Shen, Edward J Kelly, Jonathan Himmelfarb, Kenneth E Thummel
The role of megalin in the regulation of renal vitamin D homeostasis has previously been evaluated in megalin-knockout mice and rat proximal tubule epithelial cells. We revisited these hypotheses that were previously tested solely in the rodent models, this time using a 3-dimensional proximal tubule microphysiological system incorporating primary human proximal tubule epithelial cells. Using this human cell-derived model, we confirmed that 25OHD3 is transported into the human proximal tubule epithelium via megalin-mediated endocytosis while bound to vitamin D binding protein...
July 8, 2018: ALTEX
https://www.readbyqxmd.com/read/29999168/a-human-population-based-organotypic-in-vitro-model-for-cardiotoxicity-screening
#4
Fabian A Grimm, Alexander Blanchette, John S House, Kyle Ferguson, Nan-Hung Hsieh, Chimeddulam Dalaijamts, Alec A Wright, Blake Anson, Fred A Wright, Weihsueh A Chiu, Ivan Rusyn
Assessing inter-individual variability in responses to xenobiotics remains a substantial challenge, both in drug development with respect to pharmaceuticals and in public health with respect to environmental chemicals.  Although approaches exist to characterize pharmacokinetic variability, there are no methods to routinely address pharmacodynamic variability.  In this study, we aimed to demonstrate the feasibility of characterizing inter-individual variability in a human in vitro model. Specifically, we hypothesized that genetic variability across a population of iPSC-derived cardiomyocytes translates into reproducible variability in both baseline phenotypes and drug responses...
July 8, 2018: ALTEX
https://www.readbyqxmd.com/read/29901209/material-mediated-pyrogens-in-medical-devices-applicability-of-the-in-vitro-monocyte-activation-test
#5
Lindsey K Borton, Kelly P Coleman
Pyrogenicity presents a challenge to clinicians, medical device manufactures, and regulators. A febrile response may be caused by endotoxin contamination, microbial components other than endotoxin, or chemical agents that generate a material-mediated pyrogenic response. While test methods for the assessment of endotoxin contamination and some microbial components other than endotoxin are well-established, material-mediated pyrogens remain elusively undefined. This review presents the findings of literature searches conducted to identify material-mediated pyrogens associated with medical devices...
June 14, 2018: ALTEX
https://www.readbyqxmd.com/read/29901211/adaptation-of-the-human-cell-line-activation-test-h-clat-to-animal-product-free-conditions
#6
Alexander Edwards, Lottie Roscoe, Christopher Longmore, Fiona Bailey, Bushra Sim, Carol Treasure
Skin sensitisers are substances that can elicit allergic responses following skin contact and the process by which this occurs is described as skin sensitisation. Skin sensitisation is defined as a series of key events, that form an adverse outcome pathway (AOP). Key event three in the AOP is dendritic cell activation that can be modelled by the human Cell Line Activation Test (h-CLAT) and is typified by changes in cell surface markers CD54 and CD86 in dendritic cells. The h-CLAT is accepted at a regulatory level (OECD Test-Guideline (TG)442E) and can be used to assess skin sensitisation potential as part of an integrated approach to testing and assessment (IATA)...
June 13, 2018: ALTEX
https://www.readbyqxmd.com/read/29901210/completely-defined-co-culture-of-adipogenic-differentiated-adipose-derived-stem-cells-and-microvascular-endothelial-cells
#7
Ann-Cathrin Volz, Larissa Hack, Franziska B Atzinger, Petra J Kluger
Vascularized adipose tissue models are highly demanded as alternative to existing animal models to elucidate the mechanisms of widespread diseases, screen for new drugs or asses corresponding safety levels. Standardly used animal-derived sera therein, are associated to ethical concerns, the risk of contaminations and many uncertainties in their composition and impact on cells. Therefore their use should be completely omitted. In this study we developed a serum-free, defined co-culture medium and implemented it to set up an adipocyte-endothelial cell (EC) co-culture model...
June 13, 2018: ALTEX
https://www.readbyqxmd.com/read/29813171/in-vitro-and-in-silico-liver-models-current-trends-challenges-and-opportunities
#8
Andrey Poloznikov, Irina Gazaryan, Maxim Shkurnikov, Sergey Nikulin, Oxana Drapkina, Ancha Baranova, Alexander Tonevitsky
Most common drug development failures originate from either bioavailability problems, or unexpected toxic effects. The culprit is often the liver, which is responsible for biotransformation of a majority of xenobiotics. Liver may be modeled using "liver on a chip" devices, which may include established cell lines, primary human cells, and stem cell-derived hepatocyte-like cells. The choice of biological material along with its processing and maintenance greatly influence both the device performance and the resultant toxicity predictions...
May 28, 2018: ALTEX
https://www.readbyqxmd.com/read/29697852/a-standardized-method-based-on-pigmented-epidermal-models-evaluates-sensitivity-against-uv-irradiation
#9
Freia F Schmid, Florian Groeber-Becker, Stefanie Schwab, Sibylle Thude, Heike Walles, Jan Hansmann
To protect the human skin from extensive solar radiation, melanocytes produce melanin and disperse it via melanosomes to keratinocytes in the basal and suprabasal layers of the human epidermis. Moreover, melanocytes are associated with pathological skin conditions such as vitiligo and psoriasis. Thus, an in vitro skin model that comprises a defined cutaneous pigmentation system is highly relevant in cosmetic, pharmaceutical and medical research. Here, we describe how the epidermal-melanin-unit can be established in vitro...
April 13, 2018: ALTEX
https://www.readbyqxmd.com/read/29697851/advanced-good-cell-culture-practice-for-human-primary-stem-cell-derived-and-organoid-models-as-well-as-microphysiological-systems
#10
David Pamies, Anna Bal-Price, Christophe Chesné, Sandra Coecke, Andras Dinnyes, Chantra Eskes, Regina Grillari, Gerhard Gstraunthaler, Thomas Hartung, Paul Jennings, Marcel Leist, Ulrich Martin, Robert Passier, Jens C Schwamborn, Glyn N Stacey, Heidrun Ellinger-Ziegelbauer, Mardas Daneshian
A major reason for the current reproducibility crisis in the life sciences is the poor implementation of quality control measures and reporting standards. Improvement is needed, especially regarding increasingly complex in vitro methods. Good Cell Culture Practice (GCCP) was an effort from 1996 to 2005 to develop such minimum quality standards also applicable in academia. This paper summarizes recent key developments in in vitro cell culture and addresses the issues resulting for GCCP, e.g. the development of induced pluripotent stem cells (iPSCs) and gene-edited cells...
April 13, 2018: ALTEX
https://www.readbyqxmd.com/read/29536108/investigation-of-ruminant-xenobiotic-metabolism-in-a-modified-rumen-simulation-system-rusitec
#11
Barbara Birk, Alexander Stähle, Mathias Meier, Markus Palm, Dorothee Funk-Weyer, Gerhard Breves, Harald Seulberger
The approving agencies for plant protection agents request xenobiotic metabolism and residue studies in rats, farm animals and plants (e.g. EU regulation 1107/2009) according to OECD guidelines. The specific intestinal physiology of ruminants might lead to specific residues, which should be investigated very carefully. Specific aspects of xenobiotic metabolism in ruminants may arise, which are investigated by performing additional in vivo studies. The aim of the present work is to asses a modified rumen simulation system (RUSITEC) for such studies in vitro...
March 12, 2018: ALTEX
https://www.readbyqxmd.com/read/29534246/testing-vaginal-irritation-with-the-hen-s-egg-test-chorioallantoic-membrane-assay
#12
Rita Palmeira-de-Oliveira, Rita Monteiro Machado, José Martinez-de-Oliveira, Ana Palmeira-de-Oliveira
The HET-CAM (Hen's Egg Test-Chorioallantoic Membrane) assay is an in vitro alternative to the in vivo Draize Rabbit Eye test that mimics vascular changes in the chorioallantoic membrane. This qualitative method assesses the irritancy potential of chemicals. The CAM responds to injury with an inflammatory process similar to that in the rabbit eye's conjunctival tissue. Regarding topical toxicity assessment of medical devices, ISO 10993-10 states that any skin or eye irritant material shall be directly labelled as a potential vaginal irritant without animal testing, suggesting that the irritation potential for the eye and the vaginal epithelia is similar...
March 11, 2018: ALTEX
https://www.readbyqxmd.com/read/29485663/recommendation-on-test-readiness-criteria-for-new-approach-methods-in-toxicology-exemplified-for-developmental-neurotoxicity
#13
Anna Bal-Price, Helena T Hogberg, Kevin M Crofton, Mardas Daneshian, Rex E FitzGerald, Ellen Fritsche, Tuula Heinonen, Susanne Hougaard Bennekou, Stefanie Klima, Aldert H Piersma, Magdalini Sachana, Timothy J Shafer, Andrea Terron, Florianne Monnet-Tschudi, Barbara Viviani, Tanja Waldmann, Remco H S Westerink, Martin F Wilks, Hilda Witters, Marie-Gabrielle Zurich, Marcel Leist
Multiple non-animal-based test methods have never been formally validated. In order to use such new approach methods (NAMs) in a regulatory context, criteria to define their readiness are necessary. The field of developmental neurotoxicity (DNT) testing is used to exemplify the application of readiness criteria. The costs and number of untested chemicals are overwhelming for in vivo DNT testing. Thus, there is a need for inexpensive, high-throughput NAMs, to obtain initial information on potential hazards, and to allow prioritization for further testing...
February 23, 2018: ALTEX
https://www.readbyqxmd.com/read/29423527/a-high-throughput-approach-to-identify-specific-neurotoxicants-developmental-toxicants-in-human-neuronal-cell-function-assays
#14
Johannes Delp, Simon Gutbier, Stefanie Klima, Lisa Hoelting, Kevin Pinto-Gil, Jui-Hua Hsieh, Michael Aichem, Karsten Klein, Falk Schreiber, Raymond R Tice, Manuel Pastor, Mamta Behl, Marcel Leist
The (developmental) neurotoxicity hazard is still unknown for most chemicals. Establishing a test battery covering most of the relevant adverse outcome pathways may close this gap, without requiring a huge animal experimentation program. Ideally, each of the assays would cover multiple mechanisms of toxicity. One candidate test is the human LUHMES cell-based NeuriTox test. To evaluate its readiness for larger-scale testing, a proof of concept library assembled by the U.S. National Toxicology Program (NTP) was screened...
January 21, 2018: ALTEX
https://www.readbyqxmd.com/read/30008013/essential-components-of-methods-papers
#15
EDITORIAL
Marcel Leist, Jan G Hengstler
Methods papers are important for the progress of biomedical research, as they provide the essential tools to explore new questions and help to better answer old ones. However, it is often not clear how a methods paper differs from a methods protocol. Confusion between these two very different types of publication is widespread. The resultant misunderstanding contributes to a relatively poor reputation of methods research in biology despite the fact that many Nobel prizes have been awarded specifically for method development...
2018: ALTEX
https://www.readbyqxmd.com/read/30008012/promoting-3rs-in-finland
#16
EDITORIAL
Hanna Vuorenpää
No abstract text is available yet for this article.
2018: ALTEX
https://www.readbyqxmd.com/read/30008011/the-3rs-competence-centre-3rcc-better-research-with-less-animal-testing
#17
EDITORIAL
Julika Fitzi-Rathgen
No abstract text is available yet for this article.
2018: ALTEX
https://www.readbyqxmd.com/read/30008010/from-3rs-to-3d-in-vitro-alternative-models-for-replacement
#18
EDITORIAL
Andras-Laszlo Nagy, Cornel Catoi, Carmen Socaciu, Adela Pintea, Nechita A Oros, Cristina Coman, Dumitrita Rugina, Cristian T Matea, Teodora Mocan, Teresa Coccini, Uliana De Simone, Isabella De Angelis, Alessia Bertero, Yula Sambuy, Francesca Caloni
No abstract text is available yet for this article.
2018: ALTEX
https://www.readbyqxmd.com/read/30008009/regulatory-acceptance-of-read-across
#19
EDITORIAL
Megan Chesnut, Takashi Yamada, Timothy Adams, Derek Knight, Nicole Kleinstreuer, George Kass, Thomas Luechtefeld, Thomas Hartung
No abstract text is available yet for this article.
2018: ALTEX
https://www.readbyqxmd.com/read/30008008/animal-testing-and-its-alternatives-the-most-important-omics-is-economics
#20
Lucy Meigs, Lena Smirnova, Costanza Rovida, Marcel Leist, Thomas Hartung
For a long time, the discussion about animal testing vs its alternatives centered on animal welfare. This was a static warfare, or at least a gridlock, where life scientists had to take a position and make their value choices and hardly anyone changed sides. Technical advances have changed the frontline somewhat, with in vitro and in silico methods gaining more ground. Only more recently has the economic view begun to have an impact: Many animal tests are simply too costly, take too long, and give misleading results...
2018: ALTEX
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