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https://www.readbyqxmd.com/read/28596049/modern-science-for-better-quality-control-of-medicinal-products-towards-global-harmonization-of-3rs-in-biologicals-the-report-of-an-epaa-workshop
#1
Katrin Schutte, Anna Szczepanska, Marlies Halder, Klaus Cussler, Ursula G Sauer, Catrina Stirling, Sylvie Uhlrich, Iwona Wilk-Zasadna, David John, Martin Bopst, Joerg Garbe, Harrie L Glansbeek, Robin Levis, Pieter-Jan Serreyn, Dean Smith, Paul Stickings
This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations)...
June 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28595837/application-of-caenorhabditis-elegans-nematode-and-danio-rerio-embryo-zebrafish-as-model-systems-to-screen-for-developmental-and-reproductive-toxicity-of-piperazine-compounds
#2
Peter I Racz, Marjolein Wildwater, Martijn Rooseboom, Engelien Kerkhof, Raymond Pieters, Elena Santidrian Yebra-Pimentel, Ron P Dirks, Herman P Spaink, Chantal Smulders, Graham F Whale
To enable selection of novel chemicals for new processes, there is a recognized need for alternative toxicity screening assays to assess potential risks to man and the environment. For human health hazard assessment these screening assays need to be translational to humans, have high throughput capability, and from an animal welfare perspective be harmonized with the principles of the 3Rs (Reduction, Refinement, Replacement). In the area of toxicology a number of cell culture systems are available but while these have some predictive value, they are not ideally suited for the prediction of developmental and reproductive toxicology (DART)...
June 5, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/28576162/conference-report-on-tedd-3r-workshop-at-zhaw-waedenswil
#3
Elsbeth Heinzelmann
On April 7, 2017, TEDD (Tissue Engineering for Drug Development and Substance Testing) and the Animal Research Foundation joined forces at ZHAW Waedenswil to present their latest scientific results in the domain of the 3Rs of biomedical research: how to Refine, Reduce and Replace animal testing with alternative approaches.
May 31, 2017: Chimia
https://www.readbyqxmd.com/read/28552675/the-era-of-3rs-implementation-in-developmental-and-reproductive-toxicity-dart-testing-current-overview-and-future-perspectives
#4
REVIEW
Manon Beekhuijzen
Since adoption of the first globally implemented guidelines for developmental and reproductive toxicity (DART) testing for pharmaceuticals, industrial chemicals and agrochemicals, many years passed without major updates. However in recent years, significant changes in these guidelines have been made or are being implemented. These changes have been guided by the ethical drive to reduce, refine and replace (3R) animal testing, as well as the addition of endocrine disruptor relevant endpoints. Recent applied improvements have focused on reduction and refinement...
May 25, 2017: Reproductive Toxicology
https://www.readbyqxmd.com/read/28542356/the-use-of-preferred-social-stimuli-as-rewards-for-rhesus-macaques-in-behavioural-neuroscience
#5
Helen Gray, Bradley Pearce, Alexander Thiele, Candy Rowe
Macaques are often motivated to perform in neuroscientific experiments by implementing fluid restriction protocols. Daily access to water is controlled and the monkeys are rewarded with droplets of fluid for performing correct trials in the laboratory. Although these protocols are widely used and highly effective, it is important from a 3Rs perspective to investigate refinements that may help to lessen the severity of the fluid restriction applied. We assessed the use of social stimuli (images of conspecifics) as rewards for four rhesus macaques performing simple cognitive tasks...
2017: PloS One
https://www.readbyqxmd.com/read/28505100/preclinical-evaluation-of-the-efficacy-of-antivenoms-for-snakebite-envenoming-state-of-the-art-and-challenges-ahead
#6
REVIEW
José María Gutiérrez, Gabriela Solano, Davinia Pla, María Herrera, Álvaro Segura, Mariángela Vargas, Mauren Villalta, Andrés Sánchez, Libia Sanz, Bruno Lomonte, Guillermo León, Juan J Calvete
Animal-derived antivenoms constitute the mainstay in the therapy of snakebite envenoming. The efficacy of antivenoms to neutralize toxicity of medically-relevant snake venoms has to be demonstrated through meticulous preclinical testing before their introduction into the clinical setting. The gold standard in the preclinical assessment and quality control of antivenoms is the neutralization of venom-induced lethality. In addition, depending on the pathophysiological profile of snake venoms, the neutralization of other toxic activities has to be evaluated, such as hemorrhagic, myotoxic, edema-forming, dermonecrotic, in vitro coagulant, and defibrinogenating effects...
May 13, 2017: Toxins
https://www.readbyqxmd.com/read/28504918/sheep-placenta-cotyledons-a-noninvasive-source-of-ovine-mesenchymal-stem-cells
#7
Iris Ribitsch, Souyet Chang-Rodriguez, Monika Egerbacher, Simone Gabner, Sinan Gueltekin, Johann Huber, Therese Schuster, Florien Jenner
Sheep are one of the most frequently used large animal models in stem cell research. However, minimal invasive or noninvasive sources of mesenchymal stem cells (MSCs) in sheep are scarce. In the light of the principles of the 3Rs (reduce, refine, replace), it would therefore be desirable to identify a minimally invasive or noninvasive ovine MSC source. In humans, the chorionic villi of the placenta, which can be noninvasively harvested as part of the afterbirth, have been identified as a rich source of MSCs...
May 2017: Tissue Engineering. Part C, Methods
https://www.readbyqxmd.com/read/28443181/development-of-a-test-method-for-the-evaluation-of-dna-damage-in-mouse-spermatogonial-stem-cells
#8
Hye Lyun Jeon, Jung-Sun Yi, Tae Sung Kim, Youkyung Oh, Hye Jeong Lee, Minseong Lee, Jin Seok Bang, Kinarm Ko, Il Young Ahn, Kyungyuk Ko, Joohwan Kim, Hye-Kyung Park, Jong Kwon Lee, Soo Jung Sohn
Although alternative test methods based on the 3Rs (Replacement, Reduction, Refinement) are being developed to replace animal testing in reproductive and developmental toxicology, they are still in an early stage. Consequently, we aimed to develop alternative test methods in male animals using mouse spermatogonial stem cells (mSSCs). Here, we modified the OECD TG 489 and optimized the in vitro comet assay in our previous study. This study aimed to verify the validity of in vitro tests involving mSSCs by comparing their results with those of in vivo tests using C57BL/6 mice by gavage...
April 2017: Toxicological Research
https://www.readbyqxmd.com/read/28429311/improving-animal-welfare-using-continuous-nalbuphine-infusion-in-a-long-term-rat-model-of-sepsis
#9
Victor Jeger, Mattia Arrigo, Florian F Hildenbrand, Daniel Müller, Paulin Jirkof, Till Hauffe, Burkhardt Seifert, Margarete Arras, Donat R Spahn, Dominique Bettex, Alain Rudiger
BACKGROUND: Sepsis research relies on animal models to investigate the mechanisms of the dysregulated host response to infection. Animal welfare concerns request the use of potent analgesics for the Refinement of existing sepsis models, according to the 3Rs principle. Nevertheless, adequate analgesia is often missing, partly because the effects of analgesics in this particular condition are unknown. We evaluated the use of nalbuphine, an opioid with kappa agonistic and mu antagonistic effects, in rats with and without experimental sepsis...
December 2017: Intensive Care Medicine Experimental
https://www.readbyqxmd.com/read/28422076/zeglobaltox-an-innovative-approach-to-address-organ-drug-toxicity-using-zebrafish
#10
Carles Cornet, Simone Calzolari, Rafael Miñana-Prieto, Sylvia Dyballa, Els van Doornmalen, Helma Rutjes, Thierry Savy, Davide D'Amico, Javier Terriente
Toxicity is one of the major attrition causes during the drug development process. In that line, cardio-, neuro-, and hepatotoxicities are among the main reasons behind the retirement of drugs in clinical phases and post market withdrawal. Zebrafish exploitation in high-throughput drug screening is becoming an important tool to assess the toxicity and efficacy of novel drugs. This animal model has, from early developmental stages, fully functional organs from a physiological point of view. Thus, drug-induced organ-toxicity can be detected in larval stages, allowing a high predictive power on possible human drug-induced liabilities...
April 19, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28409527/animal-welfare-officers-in-australian-higher-education-3r-application-work-contexts-and-risk-perception
#11
Peter J Chen
Acceptance of the concept of replacement, refinement, and reduction (the 3Rs) and the need for their implementation is widespread in the research community, and is also backed by local governance requirements in many key jurisdictions. Yet concerns about underutilization of these concepts and practices remain. From a survey of animal welfare officers (AWOs) in Australia, the attitudes to, and the adoption of, 3Rs in Australian public universities is explored. The survey finds that Australian AWOs have considerable concerns about 3R uptake, with 44% agreeing that '3R possibilities often remain unused'...
January 1, 2017: Laboratory Animals
https://www.readbyqxmd.com/read/28328898/more-than-3rs-the-importance-of-scientific-validity-for-harm-benefit-analysis-of-animal-research
#12
Hanno Würbel
No abstract text is available yet for this article.
March 22, 2017: Lab Animal
https://www.readbyqxmd.com/read/28322894/inflammation-and-immunogenicity-limit-the-utility-of-the-rabbit-as-a-nonclinical-species-for-ocular-biologic-therapeutics
#13
Christina L Zuch de Zafra, Vito G Sasseville, Steven Matsumoto, Christian Freichel, Mark Milton, Timothy K MacLachlan, Cindy Farman, Iona Raymond, Swati Gupta, Ronald Newton, Elke-Astrid Atzpodien, Evan A Thackaberry
The nonclinical safety evaluation of therapeutic drug candidates is commonly conducted in two species (rodent and non-rodent) in keeping with international health authority guidance. Biologic drugs typically have restricted species cross-reactivity, necessitating the evaluation of safety in non-human primates and thus limiting the utility of lower order species. Safety studies of cross-reactive ocular biologic drug candidates have been conducted in rabbits as a second toxicology species, despite the fact that rabbits are not a rodent species...
March 16, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28321041/evaluation-of-a-general-toxicity-study-incorporating-phototoxicity-assessments-in-sprague-dawley-rats
#14
Yutaka Yonezawa, Taishi Miyashita, Hiroko Ashizawa, Kazuto Hashimoto, Hiroaki Nejishima, Haruko Ogawa
Previously, we showed that phototoxicity assessments in Sprague-Dawley (SD) rats can detect phototoxic potential to the same degree as those in guinea pigs. In this study, we examined whether phototoxicity assessments can be incorporated into general toxicology studies, using SD rats. Three phototoxic compounds were tested. Acridine and 8-methoxypsoralen (8-MOP) were transdermally administered, and 8-MOP and lomefloxacin were orally administered. The animals were allocated to three groups for each compound: single-dose, repeated-dose, and repeated-dose plus toxicokinetics (TK)...
2017: Journal of Toxicological Sciences
https://www.readbyqxmd.com/read/28263526/bioindicators-of-wastewater-ecotoxicity
#15
REVIEW
Gabriela Jirova, Zdenka Wittlingerova, Magdalena Zimova, Alena Vlkova, Martina Wittlerova, Marketa Dvorakova, Dagmar Jirova
Wastewater, especially containing hospital effluents, exhibits high chemical complexity and specificity since it includes various chemicals, biocides, pharmaceuticals, surfactants, radionuclides, disinfectants and pathogens. Biological tests provide true evidence of the wastewater quality and unlike chemical analytical tests show comprehensive pollution effects on the environment and human health. Normalized conventional bioassays are not sensitive enough for ecotoxicological evaluation of wastewater and there is a great need for the development of suitable sensitive bioassays in order to characterize properly the residual toxicity of treated effluents...
December 18, 2016: Neuro Endocrinology Letters
https://www.readbyqxmd.com/read/28251926/phosphoregulation-of-tau-modulates-inhibition-of-kinesin-1-motility
#16
Jamie L Stern, Dominique V Lessard, Gregory J Hoeprich, Gerardo A Morfini, Christopher L Berger
Microtubule-based axonal transport is tightly regulated by numerous pathways, ensuring appropriate delivery of specific organelle cargoes to selected subcellular domains. Highlighting the importance of this process, pathological evidence has linked alterations in these pathways to the pathogenesis of several neurodegenerative diseases. An important regulator of this system, the microtubule-associated protein Tau, has been shown to participate in signaling cascades, modulate microtubule dynamics, and preferentially inhibit kinesin-1 motility...
April 15, 2017: Molecular Biology of the Cell
https://www.readbyqxmd.com/read/28245867/detection-of-schistosoma-antibodies-and-exploration-of-associated-factors-among-local-residents-around-inlay-lake-southern-shan-state-myanmar
#17
Htin Zaw Soe, Cho Cho Oo, Tin Ohn Myat, Nay Soe Maung
BACKGROUND: Schistosomiasis is a chronic parasitic disease caused by blood flukes (trematode worms) of the genus Schistosoma. Its transmission has been reported in 78 countries affecting at least 258 million people world-wide. It was documented that S. japonicum species was prevalent in Shan State, Myanmar, but the serological study was not conducted yet. General objective of the present study was to detect schistosoma antibodies and explore associated factors among local residents living around Inlay Lake, Nyaung Shwe Township, and Southern Shan State, Myanmar...
March 1, 2017: Infectious Diseases of Poverty
https://www.readbyqxmd.com/read/28215928/human-platelet-lysate-is-a-successful-alternative-serum-supplement-for-propagation-of-monocyte-derived-dendritic-cells
#18
Urban Švajger
BACKGROUND AIMS: Clinical protocols for dendritic cell (DC) generation from monocytes require the use of animal serum-free supplements. Serum-free media can also require up to 1% of serum supplementation. In addition, recommendations based on the 3Rs (Refinement, Reduction, Replacement) principle also recommend the use of non-animal sera in in vitro studies. The aim of this study was to explore the potential use of platelet lysate (PL) for generation of optimally differentiated DCs from monocytes...
February 16, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28214916/facial-expression-an-under-utilised-tool-for-the-assessment-of-welfare-in-mammals
#19
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/28170173/the-3rs-of-cell-therapy
#20
Arnold I Caplan, Chris Mason, Brock Reeve
The 3Rs for a good education are "reading, 'riting, and 'rithmetic." The basis for good health care solutions for the emergent field of cell therapy in the future will also involve 3Rs: regulation, reimbursement, and realization of value. The business models in this new field of cell therapy will involve these 3Rs. This article brings forth realities facing this new industry for its approaches to provide curative health care solutions. Stem Cells Translational Medicine 2017;6:17-21.
January 2017: Stem Cells Translational Medicine
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