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ILAR Journal

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https://www.readbyqxmd.com/read/28053083/the-guide-for-the-care-and-use-of-laboratory-animals
#1
(no author information available yet)
No abstract text is available yet for this article.
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053082/in-the-next-issue
#2
(no author information available yet)
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December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053081/ilar-council
#3
(no author information available yet)
No abstract text is available yet for this article.
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053080/about-ilar
#4
(no author information available yet)
No abstract text is available yet for this article.
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053079/ilar-journal-recent-issues-2014-2015
#5
(no author information available yet)
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December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053078/ilar-publications
#6
(no author information available yet)
No abstract text is available yet for this article.
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053077/animal-research-the-3rs-and-the-internet-of-things-opportunities-and-oversight-in-international-pharmaceutical-development
#7
Steven M Niemi, Gail F Davies
Stages of drug (and vaccine) discovery and evaluation that involve laboratory animals increasingly occur via scientific collaborations across national borders and continents. Many of these research collaborations are between asset-rich institutions and others in less wealthy parts of the world. The care and use of laboratory animals in geographically disparate locations introduces new complexities, such as different oversight requirements and available resources, as well as diverse organizational and cultural milieus...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053076/opportunities-to-apply-the-3rs-in-safety-assessment-programs
#8
Fiona Sewell, Joanna Edwards, Helen Prior, Sally Robinson
Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053075/refinement-reduction-and-replacement-of-animal-toxicity-tests-by-computational-methods
#9
Kevin A Ford
Widespread public and scientific interest in promoting the care and well-being of animals used for toxicity testing has given rise to improvements in animal welfare practices and views over time, as well as laws and regulations that support means to reduce, refine, and replace animal use (known as the 3Rs) in certain toxicity studies. One way these regulations continue to achieve their aim is by promoting the research, development, and application of alternative testing approaches to characterize potential toxicities either without animals or with minimal use...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053074/promoting-adoption-of-the-3rs-through-regulatory-qualification
#10
Elizabeth Gribble Walker, Amanda F Baker, John-Michael Sauer
One mechanism to advance the application of novel safety assessment methodologies in drug development, including in silico or in vitro approaches that reduce the use of animals in toxicology studies, is regulatory qualification. Regulatory qualification, a formal process defined at the the U. S. Food and Drug Administration and the European Medicines Agency, hinges on a central concept of stating an appropriate "context of use" for a novel drug development tool (DDT) that precisely defines how that DDT can be used to support decision making in a regulated drug development setting...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053073/in-vivo-imaging-in-pharmaceutical-development-and-its-impact-on-the-3rs
#11
Barry R Campbell, Dinko Gonzalez Trotter, Catherine D G Hines, Wenping Li, Manishkumar Patel, Weisheng Zhang, Jeffrey L Evelhoch
It is well understood that the biopharmaceutical industry must improve efficiency along the path from laboratory concept to commercial product. In vivo imaging is recognized as a useful method to provide biomarkers for target engagement, treatment response, safety, and mechanism of action. Imaging biomarkers have the potential to inform the selection of drugs that are more likely to be safe and effective. Most of the imaging modalities for biopharmaceutical research are translatable to the clinic. In vivo imaging does not require removal of tissue to provide biomarkers, thus reducing the number of valuable preclinical subjects required for a study...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053072/the-promise-of-new-technologies-to-reduce-refine-or-replace-animal-use-while-reducing-risks-of-drug-induced-liver-injury-in-pharmaceutical-development
#12
Frank D Sistare, William B Mattes, Edward L LeCluyse
Drug induced liver injury (DILI) has contributed more to marketed pharmaceutical withdrawals and clinical development failures than any other human organ toxicity. DILI seen in animal studies also frequently leads to the discontinuation of promising drug candidates very early in the pipeline. This manuscript reviews and critically assesses the current regulatory expectations; the current drug development approaches, strategies, and gaps; and the numerous exciting opportunities becoming available to address these gaps through technological advances...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053071/mouse-models-for-drug-discovery-can-new-tools-and-technology-improve-translational-power
#13
Aamir Zuberi, Cathleen Lutz
The use of mouse models in biomedical research and preclinical drug evaluation is on the rise. The advent of new molecular genome-altering technologies such as CRISPR/Cas9 allows for genetic mutations to be introduced into the germ line of a mouse faster and less expensively than previous methods. In addition, the rapid progress in the development and use of somatic transgenesis using viral vectors, as well as manipulations of gene expression with siRNAs and antisense oligonucleotides, allow for even greater exploration into genomics and systems biology...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053070/automated-microsampling-technologies-and-enhancements-in-the-3rs
#14
L David Hopper
Data collected in vivo is essential for advising decisions on drug screening and development and basic research, and animal models are used extensively for acquiring experimental measurements. Traditionally, collection of specimens has been invasive, stressful to animal subjects, labor intensive, time-consuming and costly, and required many animals when using small models with low fluid volumes, such as rats or mice. Utilizing automated microsampling (AMS) alone or in an integrative pharmacology approach to evaluate multiple physiological, pharmacokinetic, and pharmacodynamic endpoints simultaneously in the same animal accomplishes multiple experimental goals...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053069/balancing-blood-sample-volume-with-3rs-implementation-and-best-practices-for-small-molecule-toxicokinetic-assessments-in-rats
#15
Eric Harstad, Roxanne Andaya, Jessica Couch, Xiao Ding, Xiaorong Liang, Bianca M Liederer, Kirsten Messick, Trung Nguyen, Michelle Schweiger, Jacqueline Tarrant, Shelly Zhong, Brian Dean
Improved small molecule bioanalytical sensitivity and concomitant decreased sample volume requirements provide an opportunity to reconsider how toxicokinetic (TK) data are collected in rat toxicity studies. Often, satellite groups of rats are designated to separate procedural effects of TK blood collection from the primary toxicity evaluation. Blood microsampling (i.e., ≤50 μL) decreases the blood volume collected such that TK samples can be collected from toxicity groups without impacting toxicity assessment...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053068/alternative-models-of-developmental-and-reproductive-toxicity-in-pharmaceutical-risk-assessment-and-the-3rs
#16
Kimberly C Brannen, Robert E Chapin, Abigail C Jacobs, Maia L Green
In the pharmaceutical industry, preclinical developmental and reproductive toxicity studies are conducted in laboratory animals in order to predict and prevent adverse effects of drugs on human reproductive health and development. However, these studies require a relatively large number of animals and are usually conducted late in the drug development process. Early, simple, and inexpensive screening assays could facilitate smarter decisions, reductions in animal use, and development of safe drugs. The current state and future needs for alternative models of developmental and reproductive toxicity are reviewed here...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053067/drug-discovery-in-fish-flies-and-worms
#17
Kevin Strange
Nonmammalian model organisms such as the nematode Caenorhabditis elegans, the fruit fly Drosophila melanogaster, and the zebrafish Danio rerio provide numerous experimental advantages for drug discovery including genetic and molecular tractability, amenability to high-throughput screening methods and reduced experimental costs and increased experimental throughput compared to traditional mammalian models. An interdisciplinary approach that strategically combines the study of nonmammalian and mammalian animal models with diverse experimental tools has and will continue to provide deep molecular and genetic understanding of human disease and will significantly enhance the discovery and application of new therapies to treat those diseases...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053066/technological-advances-in-cardiovascular-safety-assessment-decrease-preclinical-animal-use-and-improve-clinical-relevance
#18
Brian R Berridge, A Eric Schultze, Jon R Heyen, George H Searfoss, R Dustan Sarazan
Cardiovascular (CV) safety liabilities are significant concerns for drug developers and preclinical animal studies are predominately where those liabilities are characterized before patient exposures. Steady progress in technology and laboratory capabilities is enabling a more refined and informative use of animals in those studies. The application of surgically implantable and telemetered instrumentation in the acute assessment of drug effects on CV function has significantly improved historical approaches that involved anesthetized or restrained animals...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053065/data-standardization-pharmaceutical-drug-development-and-the-3rs
#19
Laura Kaufman, Katrina Gore, Joyce Chandler Zandee
Despite the efforts, cost, and extensive use of animals for nonclinical research, only a small number of studies have methodically compared findings from animal toxicology studies to those from human clinical trials. Impediments to understanding the translation of nonclinical safety have included the lack of easy access to data and the need for extensive data curation given the diverse terminologies, formats, and data platforms in use. SEND and SDTM study data standards, developed by CDISC and about to become mandated by FDA, can address this and other drug development issues by facilitating access to data in ways that are not currently feasible...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053064/scientific-knowledge-and-technology-animal-experimentation-and-pharmaceutical-development
#20
Lewis B Kinter, Joseph J DeGeorge
Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations...
December 2016: ILAR Journal
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