Browsing by Subject "human"

Now showing 1 - 4 of 4
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    Biosimilars—Emerging Role in Nephrology
    (American Society of Nephrology, 2019-09-01) Wish, Jay B.; Medicine, School of Medicine
    The Food and Drug Administration (FDA) defines a “biosimilar” agent as a biologic that is highly similar to the reference or originator biologic product notwithstanding minor differences in clinically inactive components with no clinically meaningful differences in terms of the safety, purity, and potency. The advantage of biosimilars is that they are usually about 15%–30% less expensive than the reference product, which results in system-wide cost savings and increased patient access. Because biologic drugs are produced by living organisms, they are by nature heterogeneous and identical copies cannot be made, unlike generic versions of small-molecule drugs. Proposed biosimilars must undergo a rigorous evaluation process to demonstrate a high degree of structural and functional similarity with the reference biologic. Once that is confirmed, a stepwise process of comparison with the reference agent with regard to animal trials, pharmacokinetics/pharmacodynamics, immunogenicity, and human efficacy/safety is conducted. The experience with biosimilars in other highly regulated markets where patent protection for originator biologics is not as robust as in the United States has been favorable in terms of safety, efficacy, and cost savings. An FDA approval pathway was created in 2009 to expedite the approval of biosimilars; as of early 2018 nine agents had been approved through that pathway, none in nephrology. The first United States biosimilar epoetin was approved on May 15, 2018, but does not have an interchangeability designation, meaning that prescribers must specifically write for the biosimilar product for patients to receive it. Given the unfamiliarity of biosimilars within the nephrology community it is recommended that educational programs be developed to address this unmet need and for research to be conducted addressing the perceptual, clinical, and economic effect of biosimilars on our patients.
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    Robust Understanding of Motor Imagery EEG Pattern in Voice Controlled Prostatic Arm Design
    (Office of the Vice Chancellor for Research, 2015-04-17) Ghane, Parisa; Maridi, Divya; Hossain, Gahangir
    Introduction: Understanding neural mechanism of communication between human and machine has become more interesting research issue in last few decades. One of the most motivating purposes is to help the people with motor disabilities. This excites researchers to work on the interaction between brain-computer-interfacing (BCI) systems, which in turn needs a fast and accurate algorithm to decode the commands in the brain or electroencephalogram (EEG) signals. EEG signals are very noisy and contain several types of artifacts, so it would be very important to use efficient methods to train the BCI system. Aims and Goals: The goal of this project is to train an intelligent system based on the information in the sample EEG data. This system is going to predict the person’s intention in future experiments with new EEG data. Finally, this project can be used in controlling a moving object like a robot, a wheelchair, or many other devices. Data Acquisition and methods: In this project, we are working with the EEG signals taken from 20 subjects thinking about English vowels \a\, \e\, \i\, \o\, and \u\. This means we can define only 5 clusters, which contain all signals with similar features. We are going to use part of the signals for training and the rest for testing. In training section, we have to first preprocess the data, and then categorize it into 5 clusters. Robust Principle Component Analysis (PCA) helps us to analyze the data to extract the features. Afterwards based on principle component features of signals, we employ a Hidden Markov Model (HMM) classifier to send similar signals to the same cluster. As EEG data is a randomly variant signal, we are using Hybrid HMM classifier for classification of EEG pattern. Our Initial results are promising in robust understanding of auditory command, which is been explored from EEG pattern analysis.
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    Serum phospholipid fraction of polyunsaturated fatty acids is the preferred indicator for nutrition and health status in hemodialysis patients
    (Elsevier, 2016-12) Watkins, Bruce A.; Kim, Jeffrey; Tamez, Hector; Wenger, Julia; Thadhani, Ravi; Friedman, Allon N.; Department of Medicine, IU School of Medicine
    Long chain (LC) polyunsaturated fatty acids (PUFA) are major components of cell membrane phospholipids (PL) and serve as precursors for numerous bioactive lipid derivatives. Fatty acids (FA) are routinely analyzed in biological samples to assess composition of tissues, cells, and lipid fractions. In human studies, serum or plasma is often used because of their easy procurement. However, the lipid pool in serum and plasma is a mixture of triacylglycerol (TG), PL, cholesterol and its esters, and other components. Herein, we report findings from a serum FA analysis after fractionation of polar and neutral lipids by solid phase extraction in a large cohort of 400 hemodialysis patients. LC PUFA were found concentrated in the polar fraction compared to the total or the neutral lipid fraction. When correlated with clinical markers of disease, a greater number of significant correlations were found for PUFA in polar compared to total or the neutral fraction. We also observed that polar lipids are a reliable reflection of LC PUFA status compared to the total or neutral fractions because the latter are diluted by non-essential FA. The relative amounts of LC PUFA in the total and neutral fractions reflect the contribution of TG in blood that varies with diet, age, and physiologic state. Our data indicate that LC PUFA in the polar fraction are superior indicators of bioactive FA-status than in the total or the neutral fraction and should be used to establish important links between PUFA status, their bioactive substrates in hemodialysis patients.
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    What Makes Us Human?
    (Office of the Vice Chancellor for Research, 2016-04-08) Goss, Sarah; King, Justin; Smith, Rebekah; Walker, Whitney; Whitman, Priya
    What makes us human? Is it something innate within us, perhaps in our souls, if we even have them? Or are we determined by biology and genetics? It is increasingly clear that we cannot simply reduce humanity to the false dichotomies illustrated in antiquated arguments such as nature vs. nurture. Throughout history, the Cartesian mind-body divide has fueled a schism between understandings of what makes us human. Our infographic dispels these false dichotomies, indicating that humans are shaped myriad elements including genetics, socio-cultural constructs, the environment, and consciousness. This infographic shows the audience some of the greatest thinkers’ philosophies and ideas regarding areas such as human biology, consciousness, and evolution. We explain three prominent thought pathways, their roots, connotations, and interdependencies on a web of human thought, mapping out genetic foundations, theories of consciousness and human nature, and socio-cultural constructs. This web of humanity shows how the many theories of what makes us human coexist and interconnect; further indicating that humanity cannot be reduced to either the biological or the intellectual. What was once viewed as a dichotomy has become an open space for examination of human nature through the many lenses that are required for our complex nature. Perhaps the historic division of science and the humanities has provided the arena for deep thought on all sides. But now, there is a space to bridge the divide, and this bridge shows us that we are niche creators founded in biology and genetics and extant in our socio-cultural constructs. We exist in intentional space unintentionally. We are human, and perpetually evolving to be.