Comparison of Copaxone and Synthon's therapeutically equivalent glatiramer acetate.

Glatiramer acetate is indicated for the treatment of patients with relapsing forms of multiple sclerosis (RMS). In 2016, an alternative to the originator product was approved in the EU through the hybrid procedure regulatory pathway. This paper reviews the scientifically rigorous and multifaceted program undertaken to demonstrate the equivalence of this glatiramer acetate follow-on product (GTR) and the reference product Copaxone which resulted in the EU approval of GTR 20 mg/mL and 40 mg/mL.

Quality perception, purchase intention, and the impact of information on the evaluation of refined Pacific cupped oysters (Crassostrea gigas) by Dutch consumers.

Background: Oyster refinement using land-based pond systems is a new activity in the Dutch oyster sector. It increases the oyster's tissue weight and changes its sensorial properties. However, the response of Dutch consumers towards refined oysters is unknown.

The effect of algae diets (Skeletonema costatum and Rhodomonas baltica) on the biochemical composition and sensory characteristics of Pacific cupped oysters (Crassostrea gigas) during land-based refinement.

Oyster refinement, a common practice in France, is aimed at increasing the weight of oyster tissue and influencing the taste properties of the refined oysters. Refinement usually takes place in land-based systems where the oysters are fed with relatively high concentrations of microalgae. In this study the impact of feeding Skeletonema costatum and Rhodomonas baltica on the biochemical composition and sensory characteristics of Pacific cupped oysters (Crassostrea gigas) from the Eastern Scheldt during land-based refinement was studied.

Degradable PEG-folate coated poly(DMAEA-co-BA)phosphazene-based polyplexes exhibit receptor-specific gene expression.

A new cationic biodegradable polyphosphazene was developed, bearing both pendant primary and tertiary amine side groups, poly(2-dimethylaminoethylamine-co-diaminobutane)phosphazene (poly(DMAEA-co-BA)phosphazene). PEG and PEG-folate were coupled to polyplexes based on this poly(DMAEA-co-BA)phosphazene, leading to small (size 100 and 120nm, respectively) and almost neutral particles. In vitro tissue culture experiments showed a low cytotoxicity of both uncoated and coated polyplexes.

Biodegradable polymers as non-viral carriers for plasmid DNA delivery.

Gene therapy holds a great promise for the treatment of acquired and inherited diseases with a genetic origin that are currently incurable. Non-viral gene delivery systems are gaining recognition as an alternative to viral gene vectors for their potential in avoiding immunogenicity and toxicity problems inherently associated with the use of viral systems. Many cationic polymers have been studied both in vitro and in vivo for gene delivery purposes.

Biodegradable, cationic methacrylamide-based polymers for gene delivery to ovarian cancer cells in mice.

A series of cationic, methacrylamide polymers was tested for use as a biodegradable gene carrier in ovarian cancer. Tumor transfection activity of polyplexes consisting of a reporter gene and different methacrylamide polymers was assessed, after intraperitoneal injection in mice bearing an ovarian cancer xenograft. In this model, polyplexes based on poly(HPMA-DMAE) showed transfection activity similar to polyplexes based on the nondegradable and rather toxic polyethylenimine (PEI22).

Methacrylamide polymers with hydrolysis-sensitive cationic side groups as degradable gene carriers.

Water-soluble polymers with hydrolyzable cationic side groups (structure of the monomers are shown in Figure 1) were synthesized and evaluated as DNA delivery systems. The polymers, except for pHPMA-NHEM, were able to condense plasmid DNA into positively charged nanosized particles. The rate of hydrolysis at 37 degrees C and pH 7.

Characterization of volatile compounds in chilled cod (Gadus morhua) fillets by gas chromatography and detection of quality indicators by an electronic nose.

Volatile compounds in cod fillets packed in Styrofoam boxes were analyzed during chilled storage (0.5 degrees C) by gas chromatography (GC)-mass spectrometry and GC-olfactometry to screen potential quality indicators present in concentrations high enough for detection by an electronic nose. Photobacterium phosphoreum dominated the spoilage bacteria on day 12 when the fillets were rejected by sensory analysis.

In vivo tumor transfection mediated by polyplexes based on biodegradable poly(DMAEA)-phosphazene.

In recent years, increasing interest is being paid to the design of transfectants based on non-toxic and biodegradable polymers for gene therapy purposes. We recently reported on a novel, biodegradable polymer, poly(2-dimethylamino ethylamino)phosphazene (p(DMAEA)-ppz) for use in non-viral gene delivery. In this study, the biodistribution and in vivo transfection efficiency of polyplexes composed of plasmid DNA and p(DMAEA)-ppz were investigated after intravenous administration in tumor bearing mice.

Bioavailability of selenium from fish, yeast and selenate: a comparative study in humans using stable isotopes.

Objective: To measure the bioavailability of selenium from cooked and raw fish in humans by estimating and comparing apparent absorption and retention of selenium in biosynthetically labelled fish with labelled selenate and biosynthetically labelled selenium in brewers yeast.

Design: The intervention study was a parallel, randomised, reference substance controlled design carried out at two different centres in Europe.

Setting: The human study was carried out at the Institute of Food Research, Norwich, UK and at TNO Nutrition and Food Research, Zeist, The Netherlands.

Water-soluble biodegradable cationic polyphosphazenes for gene delivery.

Polyphosphazenes bearing cationic moieties were synthesized from poly(dichloro)phosphazene, which in turn was obtained by thermal polymerization of hexachlorocyclotriphosphazene in 1,2,4-trichlorobenzene. Next, either 2-dimethylaminoethanol (DMAE) or 2-dimethylaminoethylamine (DMAEA) side groups were introduced by a substitution reaction. The polymers were purified by dialysis against water and tetrahydrofuran, lyophilized and evaluated as polymeric transfectants.

Chemical and sensory evaluation of crude oil extracted from herring byproducts from different processing operations.

Fish oils extracted from marinated herring (frozen and unfrozen) byproducts and maatjes herring byproducts were evaluated on their chemical and sensory properties. The obtained crude oils had very low content of copper (<0.1 mg/kg oil), and iron values were 0.

A stereodivergent approach to substituted 4-hydroxypiperidines.

A stereodivergent route toward both diastereomeric forms of functionalized 4-hydroxypiperidines has been successfully developed. This route involves biocatalytic generation of the enantiopure starting materials followed by functionalization via N-acyliminium ion-mediated CC-bond formation.

Seasonal changes in crude and lipid composition of herring fillets, byproducts, and respective produced oils.

Crude and fatty acid composition analyses were performed on fillets, byproducts, and oil originating from herring (Clupea harengus) caught off the North Sea from June 1999 to January 2001. Monthly statistical differences were found in the fat content, the range of variation being larger in fillets than in byproducts. The most consistent change observed in fillets was an increase of unsaturation from May to September reflected in a reduced percentage of monounsaturated fatty acids, whereas for byproducts and oil this trend was not so well defined.

Composition and stability of herring oil recovered from sorted byproducts as compared to oil from mixed byproducts.

Herring oils produced from three different types of byproducts, only heads, mixed, and headless byproducts, were compared. Heads byproducts and its oil presented the highest oxidation levels and the lowest alpha-tocopherol content. Heads contained the lowest polyunsaturated fatty acids content and the highest amount of saturated fatty acids.

Upgrading of maatjes herring byproducts: production of crude fish oil.

Fish oil has been extracted from byproducts of the maatjes (salted) herring production using a pilot plant consisting of a mincer, heat exchanger, and three-phase decanter. The crude herring oil obtained had an initial peroxide value (PV), anisidine value (AV) and free fatty acids (FFA) level of only 3 mequiv of peroxide/kg of lipid, 8.9, and 2.

Characterisation of fatty acids in biological oil samples using comprehensive multidimensional gas chromatography.

Comprehensive multidimensional gas chromatography can adequately resolve very complex mixtures of analytes such as the fatty acid mixtures which are contained in, e.g., fish and vegetable oils.

Identification of fish species after cooking by SDS-PAGE and urea IEF: a collaborative study.

A collaborative study, to validate the use of SDS-PAGE and urea IEF, for the identification of fish species after cooking has been performed by nine laboratories. By following optimized standard operation procedures, 10 commercially important species (Atlantic salmon, sea trout, rainbow trout, turbot, Alaska pollock, pollack, pink salmon, Arctic char, chum salmon, and New Zealand hake) had to be identified by comparison with 22 reference samples. Some differences in the recoveries of proteins from cooked fish flesh were noted between the urea and the SDS extraction procedures used.

A standardized method of identification of raw and heat-processed fish by urea isoelectric focusing: a collaborative study.

A urea-isoelectric focusing (urea-IEF) method of identifying fish species in processed fishery products was investigated as an interlaboratory collaborative study. The technique was optimized with respect to (i) protein extraction conditions, composition of the extraction solution (urea and SDS solutions), determination of protein concentrations of the fish extracts (five tested methods); (ii) nature of gel (with carrier ampholytes and Immobilines), conditions of rehydration of commercial dry gels, urea concentration; (iii) staining conditions, Coomassie blue and silver staining. The results of various experiments were compared to select the most appropriate methodology, with respect to the discrimination power of differentiating species with the minimal influence of heat processing, reproducibility, speed, and ease of application.

Diffusibility of selenate, selenite, seleno-methionine, and seleno-cystine during simulated gastrointestinal digestion.

The present study was undertaken to evaluate the in vitro availability of chemically varying forms of selenium (Se), supplemented in cow's milk. Two inorganic (selenite and selenate) and two organic (seleno-methionine [Se-Met] and seleno-cystine [Se-Cys]) Se sources were evaluated. The in vitro availability was estimated by the diffusibility of Se during simulated gastrointestinal digestion.

Bioavailability of calcium of fresh cheeses, enteral food and mineral water. A study with stable calcium isotopes in young adult women.

True fractional Ca absorption from six foods was measured in twelve normal healthy women, aged 20-29 years. The tested foods were commercially available fresh cheese, fresh cheese prepared by new technology and rich in Ca, similar cheese with added Fe, enteral food, mineral water alone and combined with a spaghetti meal. The aim of the study was to investigate: (1) Ca absorption from a new Ca-rich fresh cheese and to compare it with that from the traditional commercial type of fresh cheese; (2) the effect of Fe enrichment of the new cheese on Ca absorption; (3) Ca absorption from the mineral water and the enteral product and to compare it with that from the dairy products; (4) the effect of a meal combined with the mineral water on Ca absorption.

Estimation of selenium bioavailability from human, cow's, goat and sheep milk by an in vitro method.

The trace element selenium (Se) has been recognized to be essential for human health. The dependence of infants on milk as their principal food source, generally low in Se content, makes them more vulnerable to inadequate Se intake. The present study compared the Se availability as estimated by a simulated gastrointestinal digestion procedure, of human milk and some common ruminant milks, namely cow, goat and sheep milk.

Modification of an in-vitro method for estimating the bioavailability of zinc and calcium from foods.

A continuous flow in-vitro method for estimating the bioavailability of minerals and trace elements was modified. This modified method includes a simulated gastric digestion with pepsin, gradual pH change during the first 30 min of dialysis in an Amicon stirred cell, and a further 2 h of continuous dialysis accompanied by intestinal digestion with pancreatin-bile extract. The percentage of continuously dialysed minerals or trace elements (dialysability) is used to express the bioavailability.

Mass spectrometric methods for studying nutrient mineral and trace element absorption and metabolism in humans using stable isotopes. A review.

Mass spectrometric methods for determining stable isotopes of nutrient minerals and trace elements in human metabolic studies are described and discussed. The advantages and disadvantages of the techniques of electron ionization, fast atom bombardment, thermal ionization, and inductively coupled plasma and gas chromatography mass spectrometry are evaluated with reference to their accuracy, precision, sensitivity, and convenience, and the demands of human nutrition research. Examples of specific applications are described and the significance of current developments in mass spectrometry are discussed with reference to present and probable future research needs.

Comparison of renal toxicity after long-term oral administration of cadmium chloride and cadmium-metallothionein in rats.

There is a clear lack of information on the toxicological risk of dietary intake of cadmium-metallothionein (CdMt). The present study aimed at establishing dose-dependent cadmium (Cd) disposition and to investigate differences in renal toxicity after long-term dietary exposure to CdMt or cadmium chloride (CdCl2) in rats. Male Wistar rats were fed diets containing 0.