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Faqi A.S.,MPI Research
Systems Biology in Reproductive Medicine | Year: 2012

The nonhuman primates (NHPs) are used in many areas of biomedical research where their similarities to humans make them exclusively valuable animal models. The use of NHPs in pre-clinical testing is expected to increase due to the increase in the development of biological compounds for therapeutic uses. The regulatory agencies around the world including Food and Drug Administration (FDA) generally requires developmental and reproductive toxicity (DART) testing of all new drugs to be used by women of childbearing age or men of reproductive potential. NHPs are most frequently used for DART testing when commonly used rodents and/or rabbits are not pharmacologically relevant species. Animal studies are unique in that assessment of reproduction and development as DART studies are not performed in controlled clinical trials; therefore, pre-clinical safety assessment forms the basis for risk assessment for marketed drug products. This paper provides a critical evaluation of developmental and reproductive toxicity studies in NHPs. The manuscript will focus on species selection, limitation of International Conference for Harmonization stages (A-F) using NHPs as a test system, study designs, logistical/technical challenges, and strength, and limitations. It will also pinpoint confounding factors inherent to the test system that may complicate the interpretation of the NHP DART data. © 2012 Informa Healthcare USA, Inc. Source


Mansueto V.,University of Palermo | Cangialosi M.V.,University of Palermo | Faqi A.S.,MPI Research
Caryologia | Year: 2011

In the present study we have determined the effects of endocrine disrupting chemicals such as Tributyltin (TBT) and Bisphenol-A (BPA) in juvenile Ciona intestinalis (Ascidiacea, Urochordata). The interest in Urochordata is due to its close phylogenetic relation to vertebrates. Moreover, in the juvenile the organs of a form similar to the adult form are present and they can easily be studied for the eventual morphological alterations that can be induced under stress conditions. Juvenile Ciona intestinalis of 4 days post fertilization were incubated for 1 h at increasing concentrations of either TBT or BPA solutions (0.1, 1 and 10 μM). The morphology of several organs was altered in a concentration-dependent manner in both TBT and BPA treated animals. BPA seems to be more toxic than TBT, destroying the tunic, the gonad cells and inhibiting the rhythmic body contractions. The TBT and BPA induced toxicity on the gonads is in agreement with previous data demonstrating that many chemicals can endanger the reproductive system leading to reproductive failure and consequently a population decline. These results suggest that the juvenile Ciona intestinalis can be used as an alternative or supplemental model for toxicological studies regarding the effects of toxicants not only on organs but also on metamorphosis and on reproductive, defense and nervous systems. Source


Zhu Y.,CAS Shanghai Institute of Materia Medica | Zhang Z.,CAS Shanghai Institute of Materia Medica | Zhang M.,CAS Shanghai Institute of Materia Medica | Mais D.E.,MPI Research | Wang M.-W.,CAS Shanghai Institute of Materia Medica
Combinatorial Chemistry and High Throughput Screening | Year: 2010

Throughout the centuries, traditional Chinese medicine has been a rich resource in the development of new drugs. Modern drug discovery, which relies increasingly on automated high throughput screening and quick hit-to-lead development, however, is confronted with the challenges of the chemical complexity associated with natural products. New technologies for biological screening as well as library building are in great demand in order to meet the requirements. Here we review the developments in these techniques under the perspective of their applicability in natural product drug discovery. Methods in library construction, component characterization, biological evaluation, and other screening approaches including NMR and X-ray diffraction are discussed. © 2010 Bentham Science Publishers Ltd. Source


Produce and other non-certified foods may be provided to laboratory animals for enrichment, but this practice can generate scientific concerns, particularly if these food items contain nutrients that are pharmacologically active or affect animals' consumption of the basal diet. The author reviews information on potential for a number of nutritional components of food items to affect study data. On the basis of published effect levels, he proposes an upper limit for the consumption of each component in enrichment items relative to the amount present in a standard basal diet. He then assesses the amounts of these nutritional components in a broad range of food enrichment items and proposes a maximum serving size for each item for several common laboratory animals. Total caloric content and sugar content are the limiting components for many enrichment food items, but most items may be used as enrichment for laboratory animals without affecting study results, as long as the amounts of the items provided are managed. © 2015 Nature America, Inc. Source


One enrichment strategy for laboratory animals is the provision of food variety and foraging opportunities. Fresh agricultural items, including produce or packaged human food items, provide variation in palatability, texture and complexity and can therefore be used as enrichment for lab animals. But concerns are often raised that these food items might sometimes carry contaminants that could affect research subjects and confound experimental results. The author discusses the potential for agriculturally sourced foods used as enrichment for lab animals to be contaminated with mycotoxins, microorganisms and pesticide residues and the effects these contaminants might have on lab animals. He also suggests strategies for reducing the risk of contamination. © 2015 Nature America, Inc. All rights reserved. Source

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