37 research outputs found

    An interlaboratory comparison on the characterization of a sub-micrometer polydisperse particle dispersion

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    The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This paper describes an interlaboratory comparison with the goal of assessing the measurement variability for the characterization of a sub-micrometer polydisperse particle dispersion composed of five sub-populations of poly(methyl methacrylate) (PMMA) and silica beads. The study included 20 participating laboratories from industry, academia, and government, and a variety of state-of-the-art particle-counting instruments. The received datasets were organized by instrument class to enable comparison of intralaboratory and interlaboratory performance. The main findings included high variability between datasets from different laboratories, with coefficients of variation from 13 % to 189 %. Intralaboratory variability was, on average, 37 % of the interlaboratory variability for an instrument class and particle sub-population. Drop-offs at either end of the size range and poor agreement on maximum counts of particle sub-populations were noted. The mean distributions from an instrument class, however, showed the size-coverage range for that class. The study shows that a poly-disperse sample can be used to assess performance capabilities of an instrument set-up (including hardware, software, and user settings) and provides guidance for the development of polydisperse reference materials.Drug Delivery Technolog

    Diversity of Agaricales (Basidiomycota) in the Reserva Biológica Walter Egler, Amazonas, Brazil

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    A study of the order Agaricales Clements (Hymenomycetes, Basidiomycotina), occurring in the Reserva Biológica Walter Egler was carried out from December 2000 to June 2001. The area of study is situated at Road AM-010, Manaus-Itacoatiara, km 64, Latitude 02° 43' S and Longitude 59° 47' W, Rio Preto da Eva, in the State of Amazonas, with a total area of 709 ha of terra firme rain forest. The fungi collected were identified based on traditional methodology for identification of Agaricales. A total of 39 species were studied, distributed in 13 genera and six families: Polyporaceae: Pleurotus sp.; Hygrophoraceae: Hygrocybe cf. megistospora, Hygrocybe aff. miniceps, Hygrocybe occidentalis var. scarletina and eight indeterminate species of Hygrocybe; Tricholomataceae: Clitocybe sp., Hydropus sp.1 and Hydropus sp.2, Macrocystidia sp., Marasmiellus sp., Marasmius bellus, Marasmius haedinus var. haedinus, Marasmius cf. leoninus, Marasmius cf. mazatecus, Marasmius cf. ruber, Marasmius cf. setulosifolius, Marasmius tageticolor, Marasmius cf. variabiliceps var. variabiliceps, Marasmius sp.1, Marasmius sp.2, Marasmius sp.3 and Marasmius sp.4, Tricholoma sp.; Agaricaceae: Agaricus sp.1 and Agaricus sp.2, Lepiota sp., Cystoderma sp.; Entolomataceae: Entoloma cf. azureoviride, Entoloma cf. cystidiophorum, Entoloma strigosissima, Entoloma sp.; Russulaceae: Lactarius panuoides. Entoloma azureoviride, Hygrocybe miniceps, Lactarius panuoides, Marasmius cf. mazatecus, Marasmius cf. setulosifolius and Marasmius variabiliceps var. variabiliceps, apparently are here cited for the first time from Brazil. With exception of Marasmius tageticolor, all species are cited here for the first time as occurring in Egler Forest. The tables with the species occurrence, in accordance with the topographical gradient (sand bank, incline, plateau) and its respective habitat, are supplied.", 'enFoi realizado um estudo dos representantes da Ordem Agaricales Clements (Hymenomycetes, Basidiomycotina), ocorrentes na Reserva Biológica Walter Egler, situada na Estrada AM-010, Manaus-Itacoatiara, Km 64, Latitude 02° 43' S e Longitude 59° 47' W, Rio Preto da Eva, Amazonas. A área abrange 709 ha de floresta de terra firme primária. As coletas foram realizadas no período de dezembro de 2000 a junho de 2001 e seguiu-se a metodologia usual para identificação de Agaricales. Foram estudadas um total de 39 espécies, distribuídas em 13 gêneros e seis famíliasPolyporaceaePleurotus sp.; HygrophoraceaeHygrocybe cf. megistospora, Hygrocybe aff. miniceps, Hygrocybe occidentalis var. scarletina, e mais oito espécies de Hygrocybe indeterminadas; TricholomataceaeClitocybe sp., Hydropus sp.1 e Hydropus sp.2, Macrocystidia sp., Marasmiellus sp., Marasmius bellus, Marasmius haedinus var. haedinus,Marasmius cf. leoninus, Marasmius cf. mazatecus, Marasmius cf. ruber,Marasmius cf. setulosifolius, Marasmius tageticolor, Marasmius cf. variabiliceps var. variabiliceps, Marasmius sp.1, Marasmius sp.2, Marasmius sp.3 e Marasmius sp.4, Tricholoma sp.; AgaricaceaeAgaricus sp.1 e Agaricus sp.2, Lepiota sp., Cystoderma sp.; EntolomataceaeEntoloma cf. azureoviride, Entoloma cf. cystidiophorum, Entoloma strigosissima, Entoloma sp.; RussulaceaeLactarius panuoides. Destas, Entoloma azureoviride, Hygrocybe miniceps, Lactarius panuoides, Marasmius cf. mazatecus, Marasmius cf. setulosifolius e Marasmius variabiliceps var. variabiliceps, provavelmente, estão sendo aqui citadas pela primeira vez, para o Brasil. Com exceção de Marasmius tageticolor, as demais espécies são citadas pela primeira vez, para a Reserva Egler. São fornecidas tabelas com a ocorrência das espécies de acordo com o gradiente topográfico (baixio, vertente, platô) e seus respectivos habitats

    Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

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    BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

    Effect of anti-androgenic substances on the sexual reproduction of the rotifer Brachionus calyciflorus.

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    Many substances released in the aquatic environment have been reported to have disruptive effects on endocrine systems of vertebrates and invertebrates. In rotifers, some of these chemicals have been shown to depress sexual reproduction at concentrations one to two orders of magnitude below those that affect asexual reproduction. The anti-androgen flutamide impacts sexual reproduction of rotifers at particularly low concentrations. We studied the effect of different types of putative endocrine disruptors on sexual reproduction of Brachionus calyciflorus. Contaminants tested were cyproterone acetate, an anti-androgen with a steroid-like structure, the pesticides fenitrothion and linuron which both have high affinity to the androgen receptor in vertebrates, although they are nonsteroidal molecules, and lindane a widely used pesticide that binds weakly to the androgen receptor in vertebrates. A series of endpoints relative to different steps of sexual reproduction were monitored to define critical functions affected and to get information on mechanisms of action. Fenitrothion, had the strongest impact on the sexual reproduction of rotifers. We observed a decrease in the proportion of mictic females among the ovigerous individuals and in the production of fertilized eggs per female that was proportional to the dose. The most sensitive parameter was the number of males produced per mictic female which was considerably higher in treated animals even at concentrations 10 times lower than the NOEC of asexual reproduction

    EFFECT OF ANTI-ANDROGENIC SUBSTANCES ON THE SEXUAL REPRODUCTION OF ROTIFERS : IMPACTS ON BRACHIONUS CALYCIFLORUS MALE FERTILITY

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    Many substances released in aquatic ecosystems have been reported to disrupt endocrine systems in vertebrates and invertebrates. In the rotifer Brachionus calyciflorus, studies show that chemicals characterized by a high affinity to the vertebrate androgen receptor depress sexual reproduction at concentrations one to two orders of magnitude below those that affect asexual reproduction. We studied the effect of cyproterone acetate, an anti-androgen of steroid like structure, and of the pesticide fenitrothion, a non steroidal molecular which has a high affinity to the vertebrate androgen receptor, on the sexual reproduction of rotifers. In mating experiments we crossed control females with exposed males and vice versa to determine whether anti-androgens affected males, females or both. Fertilization rate and number of resting eggs produced were affected by both substances tested. With fenitrothion, depression of these endpoints was observed exclusively when males were treated. Cyproterone acetate enhanced production of resting eggs whereas fertilization rate was not significantly affected. Increased production of resting eggs was observed both with treated females and males. Parameters of male fertility were compared in control and in exposed males. We report impacts on spermatozoa numbers, morphology and fertilizing potential, and on male morphology, longevity and mating behaviour for the two substances tested

    Bromophycolides C-I from the Fijian red alga Callophycus serratu

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    Bromophycolides C-I (1-7) were isolated from extracts of the Fijian red alga Callophycus serratus and identified by NMR and mass spectral techniques. These novel natural products share a carbon skeleton and biosynthetic origin with previously identified bromophycolides A (8) and B (9), which form a rare group of diterpene-benzoate macrolides. Bromophycolides C-I (1-7) displayed modest antineoplastic activity against a range of human tumor cell lines
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