1,631 research outputs found

    Etnofarmakologi dan Pemakaian Tanaman Obat Suku Dayak Tunjung di Kalimantan Timur

    Full text link
    Modern medicine has been known by people in East Kalimantan including Dayak Tunjung tribe, but until now they still maintain their tradition in utilizing plants in the forest and the surrounding area for curing various diseases. The empirical experience and knowledge from them are very valuable information for developing new drugs. Field study recorded 47 plant species were being used as medicinal plants by Dayak Tunjung people in East Kalimantan. Further research need to be done to analyze the chemical compounds of these medicinal plants and also the safe dosage of its use

    Comparability and similarity protocols for biotechnology products

    Get PDF
    Over lifecycle, from development through all industrialization stages and then over manufacturing history across multiple sites, a biotechnology product must show very high levels of quality consistency, as that is a pre-requisite for safety and efficacy to patients (cf. ICH Q5E, 2004). Recently, FDA defined different levels of similarity (Draft Guidance, May 2014, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”) namely the concepts of (1) “highly similar with fingerprint-like similarity” and that of (2) “residual uncertainty” in regard to similarity. Here we present a new approach to combine whole analytical domains from different techniques used in comparability protocols (to support change management for same product and process) that also is applicable to assess similarity in biocomparability investigations. Our approach ensures much higher levels of confidence in Comparability Protocols by not overlooking differences that might be unnoticed or overlooked due to incomplete prior-knowledge in regards to methods used and attributes considered. Our approach can (a) detect very small differences, (b) establish therefore the exact level of comparability / similarity and (c) provides a sound statistical foundation to assess residual uncertainties. We will illustrate our approach on reference products over their lifecycle and to compare reference with putatively similar products. The outcome of assessments (a) through (c) can then be linked to pharmacological performance or both types of biotechnology products, and support regulatory or other decisions related to managing filings

    Integrating analysis with process control for continuous bioprocessing: Extending the lifecycle concept to process analytical technologies

    Get PDF
    The most notable trends in the use of PAT tools in bioprocessing nowadays are: (1) the combined use of multiple tools to a product & process and (2) that information fusion provides a better process estimation and product quality knowledge foundation than the use classical use of one analytical method The lifecycle management aspects of validation launched by FDA in its 2011 Validation Guidance, arrived - through ICH Q11 (2012) and the forth coming ICH Q12 (2017), to all aspects of development, qualification and commercial manufacturing of large molecule drug substances. For continuous bioprocessing that challenges are significantly different and more complex than for batch processing of small molecules. The homeostasis state that are targeted for most continuous bioprocesses, puts specific requirements in each individual PAT tool chosen and in their combined use over lifecycle. Here, using case-studies, a discussion is done of specific challenges at each of the three stages of lifecycle, about how and when the shift is made from understanding (acquiring data & information) to enhanced bioprocess control (knowledge-based decisions) to realize product quality by design (predictive product quality). Finally, we show how platform knowledge can be managed across multiple products for a company’s own portfolio benefit, through aggregation and high-level visualization of multiple PAT projects

    Effect of Steamed Broccoli Juice (Brassica Oleraceae L. Var. Italica) to the Serum Interleukin 8 Level in Colitis Murine Model

    Get PDF
    Background: Ulcerative colitis (UC) is a bowel inflammation that happens in the colon and rectum. In UC there is an increased level of inflammatory mediators, one of which is interleukin-8 (IL-8), the main chemoattractant for polymorphonuclear (PMN) inflammatory cells causing inflammation to worsen. Broccoli (Brassica oleraceae L. var. italica) contains sulforaphane which can inhibit nuclear factor kappa B (NF-ĸB), resulting in the decrease of IL-8. This study was performed to identify the effect of steamed broccoli juice to the serum interleukin-8 level in murine model of colitis.Method: This study was a true experimental laboratory study using complete randomized design. Experimental animals being used were 28 murines with Balb/c strain and were divided into 4 intervention groups. Serum IL-8 level was measured by using enzyme-linked immunosorbent assay (ELISA) method. Data analysis was performed using analysis of variance (ANOVA) test, followed by multiple comparisons Tukey honest significant difference (HSD) test (a = 0.05) and p 0.05.Results: The highest mean of IL-8 level was found in the positive control group. This study also showed highly significant difference (p < 0.001) of IL-8 level between positive control group and treatment group.Conclusion: Steamed broccoli juice could decrease serum interleukin-8 level in murine model of colitis

    Developing A Web-based Argumentative Writing Media For Students Of English Department

    Full text link
    A research and development was conducted to address the problem of teaching and learning argumentative course. The teaching of the course that implemented process writing approach took long time to conduct and required face to face meeting for guidance. An online media in form of website was developed enabling the teaching and learning to be conducted online. The website is specially designed to allow the five stages of process writing approach; planning, drafting, revising, editing, and publishing done online.Penelitian pengembangan ini dilakukan sebagai solusi dari permasalahan belajar dan pembelajaran matakuliah menulis argumentatif. Pembelajaran menulis argumentatif menggunakan pendekatan process writing yang memerlukan waktu lama serta mengharuskan adanya tatap muka untuk dilakukan. Sebuah media pembelajaran online dalam bentuk website dikembangkan untuk memungkinkan pembelajaran menulis argumentatif dilaksanakan secara online. Website ini dirancang secara khusus untuk dapat memfasilitasi lima tahap pembelajaran menggunakan pendekatan process writing; perencanaan, penulisan, revisi, penyuntingan, dan publikasi untuk dapat dilakukan secara online

    Development of an electrochemical biosensor for Machado-Joseph disease biomarker detection

    Get PDF
    [Excerpt] Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is a neurodegenerative disease with an autosomal dominant inheritance pattern. Nowadays, it is the most common form of spinocerebellar ataxia and an incurable disorder, which leads to death1. MJD is caused by the expansion of CAG trinucleotide repeat in the coding region of the gene ATXN3 and the aggregation of the resulting product. This polyQ expansion is thought to be the key of the disease, in which the length of this polyQ extension is linked to earlier and more severe symptons2. This mutant protein disturbs the normal neuronal function and leads to its degeneration, with subsequent formation of neuronal intranuclear inclusions. Although there is no treatment available, a more accurate diagnosis of MJD may lead to relieved symptoms2. Research activities targeting such possibility include the identification of biomarkers in several biological fluids that may turn out an important means to early diagnosis or even potential therapy biomarkers within future3,4. [...]Funding of project IBEROS, Instituto de BioingenierĂ­a en Red para el Envejecimiento Saludable, POCTEP/0245-BEROS-1-E, PROGRAMA INTERREG 2014-2020, to FEDER within the cooperation region of Galiza/Spain and North of Portugalinfo:eu-repo/semantics/publishedVersio

    Influence of estimated training status on anti and pro-oxidant activity, nitrite concentration, and blood pressure in middle-aged and older women

    Get PDF
    The purpose of this study was to compare the association between anti and pro-oxidant activity, nitrite concentration, and blood pressure (BP) in middle-aged and older women with different levels of estimated training status (TS). The sample consisted of 155 females (50-84 years) who were submitted to a physical examination to evaluate estimated TS through the "Functional Fitness Battery Test," BP measurements, and plasma blood samples to evaluate pro-oxidant and antioxidant activity and nitrite concentrations. Participants were separated by age into a middle-aged group (< 65 years) and an older (≥65 years) group and then subdivided in each group according to TS. Blood biochemistry was similar between groups. On the other hand, protein oxidation was lower in participants with higher TS, independent of age. Older females with higher TS presented higher nitrite concentrations, lower lipoperoxidation, and lower values of BP compared with those with lower TS. Lower GPx activity was observed in participants with higher TS compared with middle-aged with lower TS. Thus, our results suggest that good levels of TS may be associated with lower oxidative stress and higher nitrite concentration and may contribute to maintain normal or reduced blood pressure values.Fil: Jacomini, André M.. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Dias, Danielle da Silva. Universidade Nove de Julho; BrasilFil: Brito, Janaina de Oliveira. Universidade Nove de Julho; BrasilFil: da Silva, Roberta F.. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Monteiro, Henrique L.. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Llesuy, Susana Francisca. Universidade Nove de Julho; Brasil. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto de Bioquímica y Medicina Molecular. Universidad de Buenos Aires. Facultad Medicina. Instituto de Bioquímica y Medicina Molecular; ArgentinaFil: De Angelis, Kátia. Universidade Nove de Julho; BrasilFil: Amaral, Sandra L.. Universidade Estadual Paulista Julio de Mesquita Filho; BrasilFil: Zago, Anderson S.. Universidade Estadual Paulista Julio de Mesquita Filho; Brasi
    • …
    corecore