Publications by authors named "Valerie Marshall"

18 Publications

  • Page 1 of 1

Safety evaluation of a novel variant of consensus bacterial phytase.

Toxicol Rep 2020 15;7:844-851. Epub 2020 Jul 15.

DuPont Nutrition and Biosciences, 925 Page Mill Road, Palo Alto, CA, 94304, USA.

A 90-day subchronic oral toxicity study was conducted to evaluate the safety of a consensus bacterial phytase variant 6-phytase (PhyG) for use as an animal feed additive. This phytase is produced by fermentation with a fungal () production strain expressing a biosynthetic variant of a consensus bacterial phytase gene assembled ancestral reconstruction with sequence bias for the phytase from . Rats were administered PhyG daily oral gavage at dose-levels of 0 (distilled water), 250, 500 or 1000 mg total organic solids (TOS)/kg bodyweight (bw)/day (equivalent to 0, 112,500, 225,000 and 450,000 phytase units (FTU)/kg bw/day, respectively). No test article-related adverse effects were observed. A no-observed-adverse-effect level (NOAEL) for PhyG was established as 1000 mg TOS/kg bw/day, the highest test concentration. Based on this NOAEL and an estimate of broiler consumption determined from the proposed inclusion of the phytase in feed at the maximum recommended level (4000 FTU/kg), a margin of safety value of 1613 was calculated. Results of genotoxicity testing and protein toxin evaluation further confirmed PhyG to be non-genotoxic and not likely to be a protein toxin upon consumption. These data support the safety of PhyG as an animal feed additive.
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http://dx.doi.org/10.1016/j.toxrep.2020.07.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7372152PMC
July 2020

Root condensed tannins vary over time, but are unrelated to leaf tannins.

AoB Plants 2018 Aug 23;10(4):ply044. Epub 2018 Jul 23.

Department of Biological Sciences, University of Alberta, Edmonton, Alberta, Canada.

Although the negative effects of root herbivores on plant fitness are expected to be similar to those of above-ground herbivores, the study of below-ground plant defences is limited compared to the rich literature on above-ground defences. Current theory predicts that concentrations of defensive chemicals above- and below-ground should be correlated, as the evolutionary drivers that shape plant defence are similar across the whole plant. We conducted a field study to measure root condensed tannin concentrations in , and determine how they related to leaf condensed tannin concentrations, tree position within the stand (edge vs. interior), tree size, and time of year. Overall, root tannin concentrations were substantially lower than leaf tannin concentrations. At individual sampling periods, root and leaf tannin concentrations were uncorrelated with each other, and did not vary with stand position or size. Across the growing season both root and leaf tannin concentrations did show similar trends, with both highest in the early summer, and declining through mid-summer and fall. These results suggest that the mechanisms that influence leaf and root tannin levels in aspen are independent within individual stems, possibly due to different evolutionary pressures experienced by the different tissue types or in response to localized (roots vs. foliage) stressors. However, across individual stems, the similar patterns in chemical defence over time, independent of plant size or stand position indicate that larger scale processes can have consistent effects across individuals within a population, such as the relative investment in defence of tissues in the spring versus the fall. Overall, we conclude that using theories based on above-ground defence to predict below-ground defences may not be possible without further studies examining below-ground defence.
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http://dx.doi.org/10.1093/aobpla/ply044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6070047PMC
August 2018

No treatment-related effects with aryloxyalkanoate dioxygenase-12 in three 28-day mouse toxicity studies.

Regul Toxicol Pharmacol 2018 Feb 16;92:220-225. Epub 2017 Dec 16.

Dow AgroSciences LLC., 9330 Zionsville Road, Indianapolis, IN 46268, USA. Electronic address:

The aryloxyalkanoate dioxygenase-12 (AAD-12) protein is expressed in genetically modified soybean events DAS-68416-4 and DAS-444Ø6-6. Expression of the AAD-12 protein in soybeans confers tolerance to the herbicide 2,4-dichlorophenoxyacetic acid (2,4-D) providing an additional herbicide choice to farmers. This enzyme acts by catalyzing the degradation of 2,4-D into herbicidally inactive metabolites. To meet evolving interpretation of regulations in the European Union, three separate 28-day repeat-dose oral mouse studies were conducted at increasing doses of up to 1100 mg AAD-12 protein/kg bw/day. No treatment-related effects were seen in any of these three studies.
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http://dx.doi.org/10.1016/j.yrtph.2017.12.012DOI Listing
February 2018

Tracheostomy as a Comfort Measure in Children With Life-Limiting Conditions.

J Palliat Care 2017 Jul/Oct;32(3-4):89-91. Epub 2017 Nov 7.

1 Paediatric Intensive Care Unit, Our Lady's Children's Hospital, Dublin, Ireland.

Palliative care for children who can expect only a short life has expanded over the last decade. Greater understanding of the measures required to ensure comfort and acceptable quality of life within the critical care environment has grown in tandem. Some more invasive interventions may be considered a "step too far" by some practitioners, including feeding gastrostomy, contracture release, and tracheostomy. Tracheostomy can facilitate a number of measures, which may enhance the brief life of the child and their family. However, tracheostomy is associated with some challenges, which may make it less suitable for some families. We discuss 3 cases where this intervention was carried out.
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http://dx.doi.org/10.1177/0825859717740064DOI Listing
November 2018

Dietary Route of Exposure for Rabbit Developmental Toxicity Studies.

Toxicol Sci 2016 11 4;154(1):90-100. Epub 2016 Aug 4.

Dow AgroSciences, LLC, Indianapolis, Indiana, USA.

Dietary administration is a relevant route of oral exposure for regulatory toxicity studies of agrochemicals as it mimics potential human intake of the chemical via treated crops and commodities. Moreover, dietary administration of test compounds during a developmental toxicity study can deliver a prolonged and stable systemic exposure to the embryo or fetus at all stages of development. In this study, strategies were employed to optimize rabbit test material consumption via diet. Comparative toxicokinetic profiles of gavage versus dietary administration were evaluated in pregnant or non-pregnant New Zealand White rabbits for 2 novel agrochemicals with different plasma half-lives of elimination (sulfoxaflor, t = 13.5 h and halauxifen, t = 1 h). Dietary administration of sulfoxaflor resulted in stable 24-h plasma concentrations, whereas gavage administration resulted in a 3-fold fluctuation in plasma levels between C and C Dietary administration of sulfoxaflor resulted in a 2-fold higher nominal and diurnal systemic dose when compared with gavage dosing due to C-related maternal toxicity following gavage. Results with the shorter half-life molecule, halauxifen, were more striking with a 6-fold diurnal fluctuation by the dietary route compared with a 368-fold fluctuation between C and C by gavage. Furthermore, plasma halauxifen was detectable only up to 12 h following gavage but up to 24 h following dietary administration. Finally, the presence of these compounds in fetal blood samples was demonstrated, confirming that dietary exposure is appropriate for achieving fetal exposure. Collectively, the results of these studies support the use of dietary exposure in rabbit developmental toxicity studies.
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http://dx.doi.org/10.1093/toxsci/kfw141DOI Listing
November 2016

Comparative response of rat and rabbit conceptuses in vitro to inhibitors of histiotrophic nutrition.

Birth Defects Res B Dev Reprod Toxicol 2015 Feb 4;104(1):1-10. Epub 2015 Feb 4.

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan.

Histiotrophic nutrition via the visceral yolk sac is an essential nutritional pathway of the rodent conceptus, and inhibition of this pathway may cause growth retardation, malformations, and death in rodent embryos. Morphologic differences among species during early development indicate that the visceral yolk sac histiotrophic nutrition pathway may be of lesser importance in nonrodent species, including humans. Here, comparative studies were conducted with inhibitors of different steps in the visceral yolk sac histiotrophic nutrition pathway to determine whether the rabbit is similarly responsive to the rat. Early somite stage New Zealand White rabbit and Crl:CD(SD) rat conceptuses (gestation day 9, rabbits; gestation day 10, rats) were exposed for 48 hr to three different histiotrophic nutrition pathway inhibitors using whole embryo culture techniques, after which they were evaluated for growth and malformations. Cubilin antibody, an inhibitor of endocytosis, reduced growth and development and increased malformations in both rat and rabbit embryos, although the rabbit appeared more sensitive. Leupeptin, a lysosomal cysteine protease inhibitor, also impaired growth and development and increased malformations in rat embryos, while in the rabbit it induced malformations and a slight decrease in morphology score but had no effect upon growth. Trypan blue, an inhibitor of endocytosis and endosome maturation, affected all measures in both species to a similar degree at the highest concentration (2500 μg/ml), but rat embryos responded to a greater extent at lower concentrations. Although the specific adverse outcomes appear to be different, these results demonstrate that rabbits, like rats, are sensitive to inhibitors of the histiotrophic nutrition pathway.
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http://dx.doi.org/10.1002/bdrb.21134DOI Listing
February 2015

Survey of the mutagenicity of surface water, sediments, and drinking water from the Penobscot Indian Nation.

Chemosphere 2015 Feb 5;120:690-6. Epub 2014 Nov 5.

National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711, USA. Electronic address:

U.S. Environmental Protection Agency (US EPA) Regional Applied Research Effort (RARE) projects address the effects of environmental pollutants in a particular region on the health of the population in that region. This report is part of a RARE project that addresses this for the Penobscot Indian Nation (PIN), Penobscot Island, Maine, U.S., where the Penobscot River has had fish advisories for many years due to high levels of mercury. We used the Salmonella mutagenicity assay with strains TA100, TA98, YG1041, and YG1042 with and without metabolic activation to assess the mutagenic potencies of organic extracts of the Penobscot River water and sediment, as well as drinking-water samples, all collected by the PIN Department of Natural Resources. The source water for the PIN drinking water is gravel-packed groundwater wells adjacent to the Penobscot River. Most samples of all extracts were either not mutagenic or had low to moderate mutagenic potencies. The average mutagenic potencies (revertants/L-equivalent) were 337 for the drinking-water extracts and 177 for the river-water extracts; the average mutagenic potency for the river-sediment extracts was 244 revertants(g-equivalent)(-1). This part of the RARE project showed that extracts of the Penobscot River water and sediments and Penobscot drinking water have little to no mutagenic activity that might be due to the classes of compounds that the Salmonella mutagenicity assay detects, such as polycyclic aromatic hydrocarbons (PAHs), nitro-PAHs (nitroarenes), and aromatic amines. This study is the first to examine the mutagenicity of environmental samples from a tribal nation in the U.S.
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http://dx.doi.org/10.1016/j.chemosphere.2014.10.002DOI Listing
February 2015

Disposition of glycolic acid into rat and rabbit embryos in vitro.

Reprod Toxicol 2014 Jul 2;46:46-55. Epub 2014 Mar 2.

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland 48674, USA.

High dose gavage administration of ethylene glycol (EG) induces teratogenicity in rodents, but not in rabbits, resulting from saturation of intermediate EG metabolism and glycolic acid (GA) accumulation. In vivo, rat embryos sequester GA 2-4-fold higher than maternal blood, a phenomenon absent in rabbits and proposed not to occur in humans. This research explored the mechanisms of GA disposition into rat and rabbit conceptuses using whole embryo culture (WEC). Rat and rabbit embryos concentrated GA from the culture medium. In vitro to in vivo discordance in the rabbit plausibly stemmed from anatomical differences between these models. GA sequestration was attenuated at 4°C in both species. Rat embryos further demonstrated pH-dependence of GA sequestration and inhibition by D-lactic acid. These data suggest GA disposition into rat and rabbit embryos is energy- and pH-dependent, and carrier-mediated. Anatomical and maternal-to-conceptal pH gradient differences likely underlie the lack of enhanced GA disposition in non-rodent species.
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http://dx.doi.org/10.1016/j.reprotox.2014.02.005DOI Listing
July 2014

Influenza immunization during pregnancy: US regulatory perspective.

Am J Obstet Gynecol 2012 Sep 9;207(3 Suppl):S57-62. Epub 2012 Jul 9.

Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA.

Maternal immunization with inactivated influenza vaccines is an important public health strategy to protect mothers and young infants from the serious complications of influenza. Although not contraindicated in pregnant women, currently US-licensed influenza vaccines are not specifically labeled for use during pregnancy. Several postmarketing initiatives are ongoing to obtain maternal and infant safety and immunogenicity data on US-licensed inactivated influenza vaccines used in pregnant women. The Food and Drug Administration is revising its pregnancy labeling regulations to improve the characterization and communication of risks of drugs and biologics used during pregnancy. To obtain a specifically labeled indication for use of an influenza vaccine during pregnancy, adequate and well-controlled prelicensure studies are needed to obtain data on the product's safety and effectiveness and to demonstrate protection of the mother and/or infant against influenza illness.
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http://dx.doi.org/10.1016/j.ajog.2012.06.075DOI Listing
September 2012

Rabbit whole embryo culture.

Methods Mol Biol 2012 ;889:239-52

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, MI, USA.

Although the rabbit is used extensively in developmental toxicity testing, relatively little is known about the fundamental developmental biology of this species let alone mechanisms underlying developmental toxicity. This paucity of information about the rabbit is partly due to the historic lack of whole embryo culture (WEC) methods for the rabbit, which have only been made available fairly recently. In rabbit WEC, early somite stage embryos (gestation day 9) enclosed within an intact amnion and attached to the visceral yolk sac are dissected from maternal tissues and placed in culture for up to 48 h at approximately 37°C and are continuously exposed to an humidified gas atmosphere mixture in a rotating culture system. During this 48 h culture period, major phases of organogenesis can be studied including cardiac looping and segmentation, neural tube closure, and development of anlagen of the otic system, eyes and craniofacial structures, somites and early phases of limb development (up to bud stage), as well as expansion and closure of the visceral yolk sac around the embryo. Following completion of the culture period, embryos are evaluated based on several growth and development parameters and also are assessed for morphological abnormalities. The ability to sustain embryo development independent of the maternal system allows for exposure at precise development stages providing the opportunity study the direct action of a teratogen or one of its metabolites on the developing embryo. Rabbit WEC is perhaps most useful when used in conjunction with rodent WEC methods to investigate species-specific mechanisms of developmental toxicity.
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http://dx.doi.org/10.1007/978-1-61779-867-2_14DOI Listing
September 2012

A novel mode-of-action mediated by the fetal muscle nicotinic acetylcholine receptor resulting in developmental toxicity in rats.

Toxicol Sci 2012 Jun 29;127(2):522-34. Epub 2012 Mar 29.

Toxicology & Environmental Research and Consulting, The Dow Chemical Company, Midland, MI 48674, USA.

Sulfoxaflor (X11422208), a novel agricultural molecule, induced fetal effects (forelimb flexure, hindlimb rotation, and bent clavicle) and neonatal death in rats at high doses (≥ 400 ppm in diet); however, no such effects occurred in rabbit dietary studies despite achieving similar maternal and fetal plasma exposure levels. Mode-of-action (MoA) studies were conducted to test the hypothesis that the effects in rats had a single MoA induced by sulfoxaflor agonism on the fetal rat muscle nicotinic acetylcholine receptor (nAChR). The studies included cross-fostering and critical windows of exposure studies in rats, fetal ((α1)(2)β1γδ) and adult ((α1)(2)β1δε) rat and human muscle nAChR in vitro agonism experiments, and neonatal rat phrenic nerve-hemidiaphragm contracture studies. The weight of evidence from these studies supported a novel MoA where sulfoxaflor is an agonist to the fetal, but not adult, rat muscle nAChR and that prolonged agonism on this receptor in fetal/neonatal rats causes sustained striated muscle contracture resulting in concomitant reduction in muscle responsiveness to physiological nerve stimulation. Fetal effects were inducible with as little as 1 day of exposure at the end of gestation, but were rapidly reversible after birth, consistent with a pharmacological MoA. With respect to human relevance, sulfoxaflor was shown to have no agonism on human fetal or adult muscle nAChRs. Taken together, the data support the hypothesis that the developmental effects of sulfoxaflor in rats are mediated via sustained agonism on the fetal muscle nAChR during late fetal development and are considered not relevant to humans.
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http://dx.doi.org/10.1093/toxsci/kfs118DOI Listing
June 2012

Toxicokinetic profile of N-(2-aminoethyl)ethanolamine in the female Wistar rat and distribution into the late gestation fetus and milk.

Birth Defects Res B Dev Reprod Toxicol 2012 Apr 27;95(2):107-15. Epub 2012 Mar 27.

Toxicology and Environmental Research and Consulting, Dow Europe GmbH, Horgen, Switzerland.

N-(2-aminoethyl)ethanolamine (AEEA) caused aneurysms of the great vessels in rats exposed in utero and during the first days post partum, exacerbated by postnatal treatment of the lactating dams (Moore et al., 2012). The purpose of this work was to examine the systemic availability of AEEA during gestation and early lactation. The absorption of AEEA was determined following oral administration to nonpregnant and pregnant female Wistar rats. A single dose administered by gavage (0.5 or 50 mg/kg) on gestation day 18 was rapidly and extensively (>90%) absorbed from the gastrointestinal tract (absorption t(1/2) = 0.1-0.2 hr). Elimination from the plasma followed a biphasic pattern, with a rapid elimination phase (t(1/2 α) = 1.6-1.8 hr) followed by a slower phase (t(1/2 β) = 16.7-17.3 hr). Following repeated gavage administration during gestation day 17 to 19, (14) C-AEEA-derived radioactivity readily partitioned into the fetus and was evenly distributed therein, but cleared approximately twofold slower from the fetal blood and tissues than the maternal blood and chorioallantoic placenta. When administered to lactating dams during lactation days 1 to 12, (14) C-AEEA-derived radioactivity preferentially partitioned into the milk reaching levels that were between 1.6- and 2.5-fold higher than the maternal blood. Although the concentration of AEEA equivalents in the maternal blood remained quite consistent, the concentration in the milk fell by almost 40% between lactation days 4 and 12, probably reflecting an increase in milk production over this same period. We confirm exposure of the offspring to AEEA both in utero and during lactation, but that AEEA does not appear to specifically concentrate in the great vessels.
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http://dx.doi.org/10.1002/bdrb.21009DOI Listing
April 2012

Food and Drug Administration regulation and evaluation of vaccines.

Pediatrics 2011 May 18;127 Suppl 1:S23-30. Epub 2011 Apr 18.

Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 405, Rockville, MD 20850, USA.

The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.
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http://dx.doi.org/10.1542/peds.2010-1722EDOI Listing
May 2011

Determination of the structure and molecular weights of the exopolysaccharide produced by Lactobacillus acidophilus 5e2 when grown on different carbon feeds.

Carbohydr Res 2008 Feb 1;343(2):301-7. Epub 2007 Nov 1.

School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield, West Yorkshire, UK.

Lactobacillus acidophilus 5e2 when grown on skimmed milk, skimmed milk supplemented with sodium formate and skimmed milk supplemented with glucose secretes a branched heteropolysaccharide having a weight average molecular weight less than 450 kDa. The exopolysaccharide has a heptasaccharide repeat unit and is composed of D-glucose, D-galactose and N-acetyl-D-glucosamine in the molar ratio 3:3:1. Using chemical techniques and 1D and 2D-NMR spectroscopy the polysaccharide has been shown to possess the following repeat unit structure:
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http://dx.doi.org/10.1016/j.carres.2007.10.028DOI Listing
February 2008

Refinement of a morphological scoring system for postimplantation rabbit conceptuses.

Birth Defects Res B Dev Reprod Toxicol 2007 Jun;80(3):213-22

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan, USA.

Background: The rabbit is used extensively in developmental toxicity testing, yet basic information on rabbit embryo development is lacking. The goals of this study were to refine a rabbit embryo morphology scoring system, and use it to evaluate rabbit whole embryo cultures (WEC).

Methods: A total of 265 conceptuses were harvested between GD 8.0 and 12.0 (coitus = GD 0) at 6-hr intervals and examined in detail. Discreet developmental landmarks were then established for 18 morphological features and assigned scores ranging from 0 up to 6. The scoring system was then validated on a subset of randomly selected in vivo conceptuses, and was used to evaluate conceptuses grown for 12, 24, 36, or 48 hr in WEC beginning from GD 9.0 or 10.0. A few embryos also were examined using microscopic computed tomography (microCT)-based virtual histologytrade mark to assess the utility of this technology.

Results: Morphology scores of in vivo developed conceptuses increased linearly (r2 = 0.98) with advancing gestational age, from means of 0.0 on GD 8.0 to 67.9 on GD 12.0. Application of the scoring system, supplemented with evidence from Virtual histologytrade mark, indicated that the WEC system supported normal morphological development of rabbit conceptuses. However, when explanted at GD 9, the rate of development was about 20% slower than in vivo, whereas the rate of development in WEC from GD 10 was indistinguishable from in vivo.

Conclusions: This work enhances the evaluation tools available to study mechanisms of normal and abnormal development in this widely used animal testing species.
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http://dx.doi.org/10.1002/bdrb.20118DOI Listing
June 2007

Structural characterisation of a highly branched exopolysaccharide produced by Lactobacillus delbrueckii subsp. bulgaricus NCFB2074.

Carbohydr Res 2005 May;340(6):1107-11

School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK.

Lactobacillus delbrueckii subsp. bulgaricus NCFB2074 when grown in skimmed milk secretes a highly branched exopolysaccharide. The exopolysaccharide has a heptasaccharide repeat unit and is composed of glucose and galactose in the molar ratio 3:4. Using chemical techniques and 1D and 2D NMR spectroscopy the polysaccharide has been shown to possess the following repeat unit structure: [carbohydrate structure: see text].
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http://dx.doi.org/10.1016/j.carres.2005.01.038DOI Listing
May 2005

Structural characterisation of a perdeuteriomethylated exopolysaccharide by NMR spectroscopy: characterisation of the novel exopolysaccharide produced by Lactobacillus delbrueckii subsp. bulgaricus EU23.

Carbohydr Res 2003 Jan;338(1):61-7

School of Applied Sciences, University of Huddersfield, Queensgate, Huddersfield HD1 3DH, UK.

The exopolysaccharide (EPS) from Lactobacillus delbrueckii subsp. bulgaricus EU23 was perdeuteriomethylated and the perdeuteriomethylated EPS (pdm-EPS) purified by elution from a C(18) Sep-Pak cartridge. Both 1D and 2D NMR spectra were recorded for the pdm-EPS and these were interpreted to provide assignments for the individual 1H and 13C resonances of the sugar residues of the repeating unit. Using a combination of the results from monomer analysis and linkage analysis of the native EPS and the ROESY and HMBC NMR spectra of the pdm-EPS the following structure has been determined for the repeating unit:A process for characterising polysaccharides having low solubility in aqueous solution is reported.
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http://dx.doi.org/10.1016/s0008-6215(02)00354-3DOI Listing
January 2003

Clients' reactions to sexual intimacy in therapy.

Am J Orthopsychiatry 1985 Apr;55(2):183-189

Recent psychological research has increased professional and public awareness of the problem of sexual intimacy between psychotherapists and their clients. A group therapy project for people who have been sexually involved with their therapists is described, and three major clinical issues encountered in these therapy sessions are discussed.
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http://dx.doi.org/10.1111/j.1939-0025.1985.tb03432.xDOI Listing
April 1985